Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial.

ABSTRACT: CM313, a novel humanized anti-CD38 monoclonal antibody, has demonstrated therapeutic potential in autoimmune diseases. This Phase 1 trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants following single ascending doses of CM313. Fifty-one participants received CM313 or placebo by SC injection at doses of 150 mg (1:1), 300 mg (2:1), and 600 mg (2:1), or by IV infusion at 8 mg/kg (2:1). All completed the trial. Treatment-emergent adverse events occurred in 90.9% of CM313-treated participants and 83.3% of placebo-treated participants, all mild or moderate. No serious adverse events were reported. SC injections of CM313 demonstrated a notably lower incidence of infusion-related reactions (600 mg SC: 20%) than IV infusion (8 mg/kg IV: 60%). CM313 e

SUBMITTER: Yu S 

PROVIDER: S-EPMC12445284 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature