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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02033668 | Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers | PHASE1 | COMPLETED | 36 | — | — | Jan 22, 2014 | Jul 15, 2014 | May 15, 2017 | 1 | United States |
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of area under concentration time curve from time zero to infinity (AUC \[0-infinity\]) following single dose SQ and IM injection to intravenous (IV) infusion
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of AUC (0-infinity) following SQ repeat dose injections to intravenous (IV) infusion
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Participants in this arm will receive single 200 milligram (mg) dose of GSK933776 administered by IV infusion |
| Arm B | EXPERIMENTAL | Participants in this arm will receive single 200 mg dose of GSK933776 administered SQ |
| Arm C | EXPERIMENTAL | Participants in this arm will receive 50 mg dose of GSK933776 administered SQ once weekly for 4 weeks (total dose = 200 mg). |
| Arm D | EXPERIMENTAL | Participants in this arm will receive single 200 mg dose of GSK933776 administered IM |
| Name | Type | Description |
|---|---|---|
| GSK933776 for SQ administration | DRUG | Antibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks |
| GSK933776 for IM administration | DRUG | Antibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose |
| GSK933776 for IV administration | DRUG | Antibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour |
Inclusion Criteria: * Male or female subject 18 to 50 years of age at the time of signing the informed consent * In general good health as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject wit...