Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3050002 · 1 trial · 1 indication
Adverse events will be collected from the start of study treatment until the follow-up contact
Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
Triplicate 12-lead ECG will be recorded before dosing on Day 1 (Pre-dose) and a single 12-lead ECG will be obtained at all other timepoints
Vital sign measurements will include systolic and diastolic blood pressure, temperature, and pulse rate
The following PK parameters will be determined: maximum observed serum concentration (Cmax), time to Cmax (tmax), area under the serum concentration-time curve (AUC\[0-t\] and AUC\[0-infinity\]), and apparent terminal phase half-life (t1/2)
| Arm | Type | Description |
|---|---|---|
| GSK3050002 0.1 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 0.1 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects (i.e. 1 subject will be dosed with GSK3050002 and 1 with placebo before the remainder of the cohort is dosed) will be used in the cohort. |
| GSK3050002 0.5 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 0.5 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects will be used in the cohort. |
| GSK3050002 1 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 1 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects will be used in the cohort |
| GSK3050002 5 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 5 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects will be used in the cohort. |
| GSK3050002 10 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 10 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects will be used in the cohort. |
| GSK3050002 20 mg | EXPERIMENTAL | Six subjects in this cohort will receive a single dose of GSK3050002 20 mg and two subjects will receive a single dose of placebo intravenously. Sentinel subjects will be used in the cohort. |
| Name | Type | Description |
|---|---|---|
| GSK3050002 | DRUG | GSK3050002 is a white to off-white lyophilized powder that will be reconstituted with sterile water for intravenous infusion. It is available in the concentrations of 0.1 milligram (mg)/kg, 0.5 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. |
| Placebo | DRUG | Placebo contains normal saline (0.9% sodium chloride) for intravenous infusion |
Inclusion Criteria: * Male aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12- lead ECG...
GSK3050002 is an investigational small molecule being developed for ulcerative colitis, a form of inflammatory bowel disease. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its potential to treat this gastrointestinal condition.
GSK3050002 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of this investigational drug.
GSK3050002 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was a single dose escalation study designed to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug remains investigational and has not received regulatory approval.
GSK3050002 has one completed clinical trial registered under NCT01984047, titled "Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002." This Phase 1 study enrolled 49 participants in the United Kingdom and included healthy male volunteers.
No, GSK3050002 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for ulcerative colitis. The completed Phase 1 trial focused on safety and tolerability, and further studies would be needed before any regulatory approval could be considered.