Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |
GSK1995057 single dose is an investigational small molecule being developed for respiratory disorders. It is currently in Phase 1 clinical development, meaning it has not been approved and is still being studied for safety and tolerability in healthy volunteers.
GSK1995057 single dose is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.
GSK1995057 single dose is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers in the United Kingdom. The drug is investigational and has not been approved for any use.
GSK1995057 single dose has been studied in two completed Phase 1 trials: NCT01476046, which evaluated single and repeat intravenous doses in healthy subjects, and NCT01587807, which investigated single inhaled doses. Both trials were conducted in the United Kingdom and enrolled a total of 109 participants.
GSK1995057 single dose refers to a specific formulation or dosing regimen of the drug GSK1995057. The clinical trials listed for this asset include studies of both single and repeat intravenous doses, as well as single inhaled doses, all under the GSK1995057 name.