Approval Probability
TA Base Rate
Adjusted LOA
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Also known as GSK1995057
GSK1995057 single dose · 2 trials · 1 indication
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)
Presence of anti GSK1995057 binding antibodies. Where binding antibodies aredetected, levels and specificity of the antibodies will be evaluated
Plasma concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following single administration (all except Cohort 5).
Urine concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following a single administration (Part 1, except Cohort 5).
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).
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).
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).
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).
Number and type of adverse events recorded during study.
Systolic and diastolic blood pressure values before and after dosing completion.
Heart rate before and after dosing completion.
Respiration rate before and after dosing completion.
Body temperature before and after dosing completion.
Holter recording.
Lead II cardiac telemetry.
FEV1 and FVC measurements.
Clinical chemistry, haematology and routine urinalysis.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | single inhaled dose of GSK1995057 (dose 1) or placebo |
| Cohort 2 | EXPERIMENTAL | single inhaled dose of GSK1995057 (dose 2) or placebo |
| Cohort 3 | EXPERIMENTAL | single inhaled dose of GSK1995057 (dose 3) or placebo |
| Cohort 4 | EXPERIMENTAL | single inhaled dose of GSK1995057 (dose 4) or placebo |
| Cohort 5 | EXPERIMENTAL | single inhaled dose GSK1995057 (dose 4) with bronchoalveolar lavage (BAL)sampling procedure conducted approximately 30 minutes post GSK1995057 dose |
| Cohort 6 | EXPERIMENTAL | high dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure. |
| GSK1995057 | EXPERIMENTAL | Single intravenous dose |
| Placebo | PLACEBO_COMPARATOR | Single intravenous dose |
| Name | Type | Description |
|---|---|---|
| GSK1995057 | DRUG | inhaled dose (volume based on cohort) |
| bronchoalveolar lavage | PROCEDURE | BAL |
| LPS | DRUG | 50 μg |
| Placebo | DRUG | Sucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose) |
| GSK1995057 single dose | DRUG | Single intravenous dose |
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...
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GSK1995057 is an investigational small molecule developed by GSK plc for respiratory disorders. It has been studied in Phase 1 clinical trials as a single dose and as repeat intravenous doses. It is not an approved medicine and remains in clinical development.
GSK1995057 is made and developed by GSK plc, which trades under the ticker GSK. The company sponsored both Phase 1 trials of the compound, which were conducted in the United Kingdom.
GSK1995057 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies enrolled 109 participants in total and were conducted in the United Kingdom.
GSK1995057 has been studied in two completed Phase 1 trials. NCT01587807 evaluated single inhaled doses for safety, tolerability, pharmacokinetics and pharmacodynamics in 53 participants. NCT01476046 evaluated single and repeat intravenous doses in 56 healthy subjects. Both were placebo controlled and conducted in the United Kingdom.
Yes. GSK1995057 single dose refers to the same compound as GSK1995057. The single dose wording reflects the dosing schedule used in the Phase 1 trials, including the inhaled single dose study NCT01587807, rather than a different drug.
GSK1995057 has been studied for respiratory disorders. Both Phase 1 trials listed this condition, and participants were healthy volunteers aged 18 years and older. The compound is investigational, so it is not an approved treatment for any indication.