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GSK1995057 single dose

Phase 1

Respiratory Disorders | Small molecule | Other |GSK plc|Last Updated: Jun 27, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment109
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01587807A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057PHASE1 COMPLETED 53 — — Mar 28, 2012Nov 19, 2012Jun 27, 20192 United Kingdom
NCT01476046Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.PHASE1 COMPLETED 56 — — Mar 8, 2011Jun 17, 2012Jun 12, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability of ascending single inhaled doses of GSK1995057
56 Days

Adverse event reporting, Laboratory safety data (clinical chemistry, hematology, urinalysis), Vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG monitoring, Spirometry monitoring (FEV1, FVC)

Levels and specificity of anti-GSK1995057 binding antibodies.
Up to 84 Days

Presence of anti GSK1995057 binding antibodies. Where binding antibodies aredetected, levels and specificity of the antibodies will be evaluated

Plasma pharmacokinetics of ascending single inhaled doses of GSK1995057
3 days

Plasma concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following single administration (all except Cohort 5).

Urine pharmacokinetics of single inhaled doses of GSK1995057
3 Days

Urine concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following a single administration (Part 1, except Cohort 5).

Concentration of GSK1995057 in lung epithelial lining fluid after inhalation of a single dose
1 Day

Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohorts 5 \& 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 \& 6 only).

Effect of single inhaled doses of GSK1995057 on biomarkers
3 Days

Pharmacodynamic and immune function biomarkers in serum (these may include but are not limited to sTNFR1 (free and total) and IL-6) (all except Cohort 5).

Effect of single inhaled doses of GSK1995057 on biomarkers in BAL
1 Day

Bronchoalveolar lavage (BAL) neutrophil counts at 6 h post LPS exposure (Cohort 5). Other pharmacodynamic and immune function biomarkers in BAL (these may include but are not limited to TNFα and IL-6) (Cohort 5).

To explore the GSK1995057 PK-PD relationship
1 Day

Pharmacodynamic and immune function biomarkers in serum and BALF (these may include but are not limited to sTNFR1 (free and total) and IL-6). Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohort 5 and 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 and 6 only). Change from baseline in IL-8 expression in ex vivo whole blood assay (WBA).

Occurance of adverse events.
From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).

Number and type of adverse events recorded during study.

Change from baseline in blood pressure.
From start of screening until 28 days after completion of single or repeat dosing.

Systolic and diastolic blood pressure values before and after dosing completion.

Change from baseline in heart rate.
From start of screening until 28 days after completion of single or repeat dosing.

Heart rate before and after dosing completion.

Change from baseline in respiration rate.
From start of screening until 28 days after completion of single or repeat dosing.

Respiration rate before and after dosing completion.

Change from baseline in body temperature.
From start of screening until 28 days after completion of single or repeat dosing.

Body temperature before and after dosing completion.

Change from baseline in heart function.
For 24hrs during screening, then for 1 hour before dosing to 24 hours after dosing starts (in Part A subjects only, except for cohort 7).

Holter recording.

Change from baseline in heart function
From 1 hour before dosing to 12 hours after dosing starts for each dose.

Lead II cardiac telemetry.

Change from baseline in lung function.
From start of screening until 28 days after completion of single or repeat dosing.

FEV1 and FVC measurements.

Change from baseline in laboratory safety data.
From start of screening until 28 days after completion of single or repeat dosing.

Clinical chemistry, haematology and routine urinalysis.

Secondary Endpoints
Plasma pharmacokinetics of GSK1995057
From the first day of dosing until 48 hours after the completion of dosing.
Urine pharmacokinetics of GSK1995057
From 1 hour before the only dose until 48 hours after the dose.
Bronchoalveolar lavage fluid (BALF) (saline flushed into and then collected from a lung) pharmacokinetics.
At 2 hrs after the completion of the only dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALsingle inhaled dose of GSK1995057 (dose 1) or placebo
Cohort 2EXPERIMENTALsingle inhaled dose of GSK1995057 (dose 2) or placebo
Cohort 3EXPERIMENTALsingle inhaled dose of GSK1995057 (dose 3) or placebo
Cohort 4EXPERIMENTALsingle inhaled dose of GSK1995057 (dose 4) or placebo
Cohort 5EXPERIMENTALsingle inhaled dose GSK1995057 (dose 4) with bronchoalveolar lavage (BAL)sampling procedure conducted approximately 30 minutes post GSK1995057 dose
Cohort 6EXPERIMENTALhigh dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure.
GSK1995057EXPERIMENTALSingle intravenous dose
PlaceboPLACEBO_COMPARATORSingle intravenous dose
Interventions
NameTypeDescription
GSK1995057DRUGinhaled dose (volume based on cohort)
bronchoalveolar lavagePROCEDUREBAL
LPSDRUG50 μg
PlaceboDRUGSucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)
GSK1995057 single doseDRUGSingle intravenous dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range f...

Countries:United Kingdom
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Competitive Landscape -Respiratory Disorders 9 trials
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