Clinical Trial

A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus

Not Yet Recruiting Phase 1
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Summary
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with systemic lupus erythematosus (SLE). The main questions it aims to answer are: * The safety, tolerability and maximum tolerated dose (MTD) of QLS4131 for Injection in participants with SLE. * The recommended Phase 2 dose (RP2D) of QLS4131 for Injection in participants with SLE. Participants will be administered different target dose of QLS4131 for Injection only once. A step-up dosing approach will be implemented at high dose level as determined by the safety monitoring committee.
Trial Details
NCT Number NCT07001839
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Systemic Lupus Erythematosus
Enrollment 108 participants
Start Date 2025-06
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-03