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

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.

Timeline

Start

2026-01

Primary completion

2026-07

Completion

2026-12

Drugs

Indications