Recent Updates
Recently added Catalysts

CCI15106

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Jul 8, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03235726Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the DrugPHASE1 COMPLETED 52 — — Jul 13, 2017Jun 19, 2018Jul 8, 20201 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
Up to 51 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.

Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
Up to 46 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
Up to 46 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Part 2 Cohort A: Number of Participants With NSAEs and SAEs
Up to 33 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Part 2 Cohort B: Number of Participants With NSAEs and SAEs
Up to 46 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Up to 51 days

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of red blood cell \[RBC\] in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 grams \[g\]/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Up to 46 days

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Part 2: Number of Participants With Hematology Values of PCI
Up to 46 days

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Up to 51 days

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 millimole per liter \[mmol/L\]), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Up to 46 days

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Part 2: Number of Participants With Clinical Chemistry Values of PCI
Up to 46 days

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Baseline (Day -1) and Day 2

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
Day 5

Urine sample was collected from participants at indicated time point for analysis of pH.

Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Days 12 and 22

Urine samples were collected from participants at indicated time points for analysis of pH.

Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Baseline (Day -1), Days 7 and 15

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1: pH Value by Visit- Placebo
Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Baseline (Day -1), Days 7 and 15

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 2 Cohort A: pH Value by Visit- CCI15106
Baseline (Day -1) and Day 2

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Baseline (Day -1), Days 7 and 15

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Baseline (Day -1) and Day 2

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
Day 5

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Days 12 and 22

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.

Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Baseline (Day -1), Days 7 and 15

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1: Specific Gravity Value by Visit- Placebo
Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Baseline (Day -1), Days 7 and 15

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Baseline (Day -1) and Day 2

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Baseline (Day -1), Days 7 and 15

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
Up to 51 days

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 milliseconds (msec), absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.

Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
Up to 46 days

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.

Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
Up to 46 days

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.

Part 1: Number of Participants With Abnormal Telemetry Findings
Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Part 2: Number of Participants With Abnormal Telemetry Findings
Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.

Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.

Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.

Part 2: Percent Predicted FVC at Indicated Time Points
Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.

Part 1: Number of Participants With Vital Signs Values of PCI
Up to 51 days

PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) \<85 and \>160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \<45 and \>100 mmHg and heart rate \<40 and \>110 beats per minute (bpm). Data for the participants with high and low values has been reported.

Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
Up to 46 days

PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.

Part 2: Number of Participants With Vital Signs Values of PCI
Up to 46 days

PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.

Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.

Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.

Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.

Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.

Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.

Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.

Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.

Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.

Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.

Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.

Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.

Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.

Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
Days 1, 7 and 14: pre-dose, 15 minutes post-dose

Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.

Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Days 1, 7 and 14: 15 minutes post-dose

Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.

Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Days 1, 7 and 14: 20 and 60 minutes post-dose

Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.

Secondary Endpoints
Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
Up to Day 13
Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
Up to Day 13
Part 1: Number of Participants With Medical Device Incidents in CCI15106
Up to Day 19
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A, Part 1: ActiveEXPERIMENTAL60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.
Cohort A, Part 1: PlaceboPLACEBO_COMPARATOR60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.
Cohort B, Part 1: ActiveEXPERIMENTAL60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.
Cohort B, Part 1: PlaceboPLACEBO_COMPARATOR60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.
Cohort C, Part 1: bystandersNO_INTERVENTIONHealthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.
Cohort A, Part 2: ActiveEXPERIMENTAL60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.
Cohort A, Part 2: PlaceboPLACEBO_COMPARATOR60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.
Cohort B, Part 2: ActiveEXPERIMENTAL60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.
Cohort B, Part 2: PlaceboPLACEBO_COMPARATOR60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.
Interventions
NameTypeDescription
CCI15106DRUGOne capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
PlaceboDRUGOne capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Some important Inclusion Criteria: For healthy subjects and bystanders: * 18 to 65 years of age. * Healthy as determined by a doctor. * Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm durin...

Countries:United Kingdom
Unlock Eligibility Criteria