At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-part Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Intravenous and Subcutaneous Doses of GSK3858279 in Healthy Participants and to Evaluate the Efficacy of Repeat Subcutaneous Doses in Participants With Osteoarthritis of the Knee
In Brief
A Phase 1 clinical trial evaluating GSK3858279 IV, GSK3858279 SC, and 2 other interventions for Pain, Inflammatory. Completed, enrolled 97 participants across 5 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
GSK3858279 will be available as solution for injection to be administered via IV route.
GSK3858279 will be available as solution for injection to be administered via SC route.
Placebo will be available as sodium chloride solution to be administered via SC or IV route.
Placebo will be available as sodium chloride solution to be administered via SC route.