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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Eligible participants will be assigned to 1 of the 9 dose groups ranging from 0.06 μg/kg to 600 μg/kg.
incidence of treatment emergence adverse events.
Time frame: Up to 24 weeks]
Recommended Phase 2 Dose
Time frame: Approximately 24 weeks
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