A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1 Study of Firsekibart in Chinese Healthy Participants.

ABSTRACT: Firsekibart is an anti-IL-1β monoclonal antibody for treating acute gout flares in adults. This randomized, double-blind, placebo-controlled study assessed the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple ascending doses of firsekibart in healthy Chinese adults. Participants were assigned to one of the two firsekibart cohorts (120 or 200 mg) every 4 weeks for three doses and randomized in a 5:1 ratio to receive firsekibart or placebo. Twenty-four participants completed the study. After a single dose, the median T_max was 7.0 days for both firsekibart groups. Mean C_max was 16.0 and 29.2 µg/mL; AUC_0-t was 350.6 and 600.0 d·µg/mL for the 120 and 200 mg groups. Following multiple doses, the median T_max,ss was 4.0 days and

SUBMITTER: Yong X 

PROVIDER: S-EPMC12907776 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature