Clinical Trial

Safety, Tolerability, PK, PD, and Immunogenicity of QL2401 in Healthy Chinese Adults

Not Yet Recruiting Phase 1
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Record status
This record was last updated January 12, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple ascending subcutaneous doses in healthy Chinese adults. The study consists of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Participants will be randomly assigned to receive either QL2401 or placebo. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of PK parameters in SAD \& MAD; exploratory objectives include assessment of PD biomarkers and immunogenicity.
Trial Details
NCT Number NCT07331545
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Metabolic Dysfunction-Associated Steatohepatitis(MASH)
Enrollment 70 participants
Start Date 2026-01
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-12