A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)
Summary
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing. Approximately 50 OA participants will be randomized in a parallel group design to receive either GSK3858279 or placebo in a 1:1 ratio.
Timeline
- Start
- 2018-05-17
- Primary completion
- 2022-09-12
- Completion
- 2022-09-12
Outcome
Mixed primary results
registry A negative value change from baseline indicates an improvement. NCT03485365 ↗
registry Median Difference (Net) -1.18 (95% CI -2.15 to -0.20) NCT03485365 ↗
registry Median Difference (Net) -1.09 (95% CI -2.29 to 0.12) NCT03485365 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DENRAKIBART | Monoclonal antibody | — | Intravenous |