Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01984047 | Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002 | PHASE1 | COMPLETED | 49 | — | — | Jan 10, 2014 | Feb 23, 2015 | Jul 24, 2018 | 1 | United Kingdom |
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...