Clinical Trial

A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases

Not Yet Recruiting Phase 1
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Summary
This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.
Trial Details
NCT Number NCT07751315
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Enrollment 64 participants
Start Date 2026-08-11
Primary Completion 2027-11-07 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-07