NCT03485365

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)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Inflammatory

Interventions

Type	Name	Description
DRUG	GSK3858279 IV	GSK3858279 will be available as solution for injection to be administered via IV route.
DRUG	GSK3858279 SC	GSK3858279 will be available as solution for injection to be administered via SC route.
DRUG	Placebo matching to GSK3858279 (SC or IV)	Placebo will be available as sodium chloride solution to be administered via SC or IV route.
DRUG	Placebo matching to GSK3858279 (SC)	Placebo will be available as sodium chloride solution to be administered via SC route.

Timeline

• Start date: 2018-05-17
• Primary completion: 2022-09-12
• Completion: 2022-09-12
• First posted: 2018-04-02
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

5 sites across 3 countries: Germany, Poland, United Kingdom