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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)

NCT03485365 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-03-22

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2022-09-12
Completion
2022-09-12

Countries

  • Germany
  • Poland
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485365 on ClinicalTrials.gov