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NOT YET RECRUITING
NCT07331545
PHASE1

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-01

Completion Date

2026-12

Last Updated

2026-01-12

Healthy Volunteers

Yes

Interventions

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.