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AZD8154

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 8, 2019

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

AZD8154 · 1 trial · 1 indication

Phase 1 1
NCT03436316A Study to Evaluate the Safety, Tolerability and Absorption to the Blood After Administration of Single and Multiple Doses of AZD8154 in Healthy Participants.Asthma
COMPLETED78 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability and Absorption to the Blood After Administration of Single and Multiple Doses of AZD8154 in Healthy Participants.
Asthma
NCT0343631678
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Study Endpoints

Primary Endpoints

Number of participants with adverse events (Part 1 & 2)
From Day-1 up to follow-up visit (6 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses; inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with adverse events (Part 3)
From Day-1 up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal findings in 12-lead digital electrocardiography (ECG) (Part 1)
At Treatment period (Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal findings in 12-lead digital ECG (Part 2)
At Treatment Periods 1 and 2 (Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal findings in 12-lead digital ECG (Part 3)
At Treatment period (Days 1 to 15).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal pulse rate (Part 1)
From screening up to the treatment period (Day -1, Days 1 to 3)

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal pulse rate (Part 2)
From screening (Days -28 to -2) up to follow-up visit (6 ± 1 days post-dose)

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal pulse rate (Part 3)
From screening (Days-28 to -2) up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal findings in telemetry (Part 1)
At Treatment Period (Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal findings in telemetry (Part 2)
At Treatment Periods 1 (Days 1 to 3) and 2 (Days 1 to 3 and Day 4).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal findings in telemetry (Part 3)
At Treatment Period (Days 1 to 15)

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal hematology (Part 1 & Part 2)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants to healthy participants.

Number of participants with abnormal hematology (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess white blood cell count (WBC), red blood cell count (RBC), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, basophils absolute count the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal blood pressure (systolic and diastolic) (Part 1 & Part 2)
From screening up to the treatment period (Day -1, Days 1 to 3)

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses and inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal blood pressure (systolic and diastolic) (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal findings in respiratory rate (Part 1)
From screening up to the treatment period (Day -1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal findings in respiratory rate (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal findings in respiratory rate (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal physical examination (Part 1)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.

Number of participants with abnormal physical examination (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.

Number of participants with abnormal physical examination (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The brief physical examinations will include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen.

Number of participants with abnormal findings in oral body temperature (Part 1)
From screening up to Treatment period (Day -1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal findings in oral body temperature (Part 2)
From screening up to Treatment Periods 1 and 2.

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal findings in oral body temperature (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Forced expiratory volume in 1 second (FEV1) (Part 1)
At Days-28 to -2, Day -1, Days 1 to 3.

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

FEV1 (Part 2)
At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

FEV1 (Part 3)
At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Forced vital capacity (FVC) (Part 1)
At Days-28 to -2, Day -1, Days 1 to 3.

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

FVC (Part 2)
At Days-28 to -2, Day -1, Days 1 to 3, and follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

FVC (Part 3)
At Days-28 to -2, Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal electrolytes (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal electrolytes (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal electrolytes (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess serum level of sodium, potassium, calcium, and phosphate as a variable of safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal hemoglobin (Hb) (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal hemoglobin (Hb) (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal hemoglobin (Hb) (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal hematocrit (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal hematocrit (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal hematocrit (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal mean corpuscular volume (MCV) (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal mean corpuscular volume (MCV) (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal mean corpuscular volume (MCV) (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin (MCH) (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal mean corpuscular hemoglobin concentration (MCHC) (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal platelet count (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal platelet count (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal platelet count (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Number of participants with abnormal reticulocytes absolute count (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants.

Number of participants with abnormal reticulocytes absolute count (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants.

Number of participants with abnormal reticulocytes absolute count (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy participants.

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 1 & Part 2)
At Day -1, Days1 to 3 and follow-up visit (6 ± 1 days post-dose).

The DLCO assessment will be performed in Part 1 of the study. The DLCO assessments will be performed in Part 2, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the American thoracic society (ATS)/ European respiratory society (ERS) guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (Part 3)
At Day -1, Days 1 to 12, and follow-up visit (7-10 days post final dose).

The DLCO assessments will be performed in Part 2 and Part 3, only if emerging data in Part 1 indicates that it is needed. The DLCO should be performed according to the ATS/ERS guidelines. Post dose DLCO will only be performed if a reduction is observed in FEV1 or FVC (≥ 12%) starting 6 hours after IMP administration.

Number of participants with abnormal clinical chemistry (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.

Number of participants with abnormal clinical chemistry (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.

Number of participants with abnormal clinical chemistry (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: total bilirubin, unconjugated bilirubin, thyroxine (T4), thyroid stimulating hormone (TSH), triglycerides, follicle stimulating hormone (FSH), creatinine, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), cystatin C, gamma glutamyl transpeptidase, and urea.

Number of participants with abnormal urinalysis (Part 1)
From screening up to Treatment Period (Day-1, Days 1 to 3).

To assess the safety and tolerability of AZD8154 following inhaled administration of single ascending doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.

Number of participants with abnormal urinalysis (Part 2)
From screening up to follow-up visit (6 ± 1 days post-dose).

To assess the safety and tolerability of AZD8154 following inhaled and intravenous (IV) administration of single doses to healthy participants. The laboratory variables to be measured are: protein, glucose, and blood.

Number of participants with abnormal urinalysis (Part 3)
From screening up to follow-up visit (7-10 days post final dose).

To assess the safety and tolerability of AZD8154 following inhaled administration of multiple ascending doses to steady state to healthy subjects. The laboratory variables to be measured are: protein, glucose, and blood.

Secondary Endpoints

Observed maximum plasma concentration (Cmax)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
Terminal elimination rate constant (λz)
At treatment period [Days 1 to 3 (Part 1 & 2)], Day 4 (Part 2) and [Days 1 to 12 (Part 3)]
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAD Cohort 1 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 1) and 2 participants will receive placebo.
SAD Cohort 2 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 2) and 2 participants will receive placebo.
SAD Cohort 3 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 3) and 2 participants will receive placebo.
SAD Cohort 4 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 4) and 2 participants will receive placebo.
SAD Cohort 5 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 5) and 2 participants will receive placebo. Participants in this Cohort will return for a second Treatment Period after a minimum washout period of 7 to 14 days. All 6 subjects will receive an inhaled dose of AZD8154 (large particle size).
SAD Cohort 6 (Part 1)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled small particle dose 6) and 2 participants will receive placebo.
Cohort 1 (Part 2)EXPERIMENTALAll participants in this cohort will receive single IV dose of AZD8154 in Treatment Period 1 and then after washout period, will receive inhaled AZD8154 (small particle size) in Treatment Period 2.
MAD Cohort 1 (Part 3)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 8) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 8) or placebo once daily from Day 4 to Day 12.
MAD Cohort 2 (Part 3)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 9) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (Inhaled dose 9) or placebo once daily from Day 4 to Day 12.
MAD Cohort 3 (Part 3)EXPERIMENTAL6 Participants will receive AZD8154 (single inhaled dose 10) and 2 participants will receive placebo on Day 1. Participants will then receive multiple dosing of AZD8154 (inhaled dose 10) or placebo once daily from Day 4 to Day 12.

Interventions

NameTypeDescription
AZD8154DRUGSAD Part 1; 6 cohorts which receive single dosing. One cohort is invited back for large particle administration. Part 2; 1 cohort which receives IV dose and then inhaled administration of AZD8154. MAD Part 3; 3 cohorts will receive inhaled multiple dosing. Additional doses are provisional and could be adjusted based on the emerging data from the previous dose by the safety review committee (SRC).
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent before any study specific procedures. 2. Healthy male and/or female participants of non-childbearing potential aged 18 to 45 years (inclusive at the Screening Visit) with suitable veins for cannulation or repeated venipu...

Countries:Germany
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Competitive Landscape -Asthma 76 trials

CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate/ Fluticasone Propionate
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
AstraZeneca PLCAZN27PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Upstream Bio, Inc.UPB1PHASE2Verekitug
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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Frequently asked questions about AZD8154

What is AZD8154 used for?

AZD8154 is an investigational small molecule being developed by AstraZeneca for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in clinical trials.

Who makes AZD8154?

AZD8154 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is in Phase 1 clinical development for the treatment of asthma.

What phase is AZD8154 in?

AZD8154 is in Phase 1 clinical development. It is an investigational drug for asthma and has not been approved by regulatory authorities. The drug is still in early-stage clinical trials to evaluate its safety, tolerability, and how it is absorbed into the blood.

What clinical trials is AZD8154 in?

AZD8154 has one completed Phase 1 clinical trial, identified as NCT03436316. This study evaluated the safety, tolerability, and absorption into the blood after single and multiple doses of AZD8154 in healthy participants. The trial was conducted in Germany and enrolled 78 participants.

Is AZD8154 being studied in healthy volunteers?

Yes, AZD8154 has been studied in healthy volunteers. The completed Phase 1 clinical trial, NCT03436316, enrolled healthy participants aged 18 years and older in Germany. The study was randomized, double-blind, and controlled, with a total enrollment of 78 participants.