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NOT YET RECRUITING
NCT07906145
PHASE1

A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases

Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of QLS2416 injection in participants with autoimmune diseases (AID). The main questions it aims to answer are: • What is the safety and tolerability profile of single and multiple ascending doses of QLS2416 injection? This study consists of two parts. Participants will receive QLS2416 injection via subcutaneous administration in dose-escalation part and dose-expansion part. Safety assessments will be conducted throughout the study. Efficacy assessments will vary by disease indication.

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of QLS2416 Injection in Participants With Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2026-12

Completion Date

2029-12

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

QLS2416 Injection

QLS2416 is a novel biologic agent administered via subcutaneous injection. Dose levels range from 0.025 mg to 6.0 mg.