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A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Sponsor: Shanghai Qilu Pharmaceutical Research and Development Center LTD
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
Conditions
Interventions
QLS2416 Injection
QLS2416 is a novel biologic agent administered via subcutaneous injection. Dose levels range from 0.025 mg to 6.0 mg.