NCT07331545

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

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of QL2401 in Healthy Chinese Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis(MASH)

Interventions

Type	Name	Description
DRUG	QL2401	QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401.
DRUG	Placebo	Matching placebo administered via subcutaneous injection.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2026-01-12
• Last updated: 2026-01-12