Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK933776 for SQ administration · 1 trial · 1 indication
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...
GSK933776 for SQ administration is an investigational small molecule being developed by GSK plc for geographic atrophy, an ophthalmology condition. It is administered subcutaneously and is in Phase 1 clinical development. It has not been approved for any indication.
GSK933776 for SQ administration targets APP, also known as amyloid precursor protein. It is classified as a binding agent, meaning it binds to APP. This target interaction is the basis of its investigational mechanism in geographic atrophy.
GSK933776 for SQ administration is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical study of this asset in geographic atrophy.
GSK933776 for SQ administration is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program has completed one trial, with no active trials currently listed.
GSK933776 for SQ administration has been studied in NCT02033668, a Phase 1 pharmacokinetic study in healthy volunteers. The trial enrolled 36 participants, was randomized and active controlled, and was conducted in the United States. It is now completed.