Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants

Summary

This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study involving Japanese participants. The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after a single subcutaneous (SC) dose of GSK2330811 in healthy Japanese participants. GSK2330811 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds and inhibits the action of Oncostatin M (OSM) and is being developed for the treatment of Crohn's disease (CD) and Systemic sclerosis (SSc). Participants will be randomized to receive either GSK2330811 (450 milligram \[mg\]) or placebo in an approximate ratio of 7:3.

Timeline

Start

2019-12-05

Primary completion

2020-05-28

Completion

2020-05-28

Publications

• Thorsted A, Zecchin C, Berges A, Karlsson MO, Friberg LE. Predicting the Long-Term Effects of Therapeutic Neutralization of Oncostatin M on Human Hematopoiesis. Clin Pharmacol Ther. 2024 Sep;116(3):703-715. doi: 10.1002/cpt.3246. Epub 2024 Mar 19.

Drugs

Indications

No indication recorded.