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A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
Official title: A Phase Ia/Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2026-08-11
Completion Date
2028-06-30
Last Updated
2026-08-07
Healthy Volunteers
Yes
Interventions
Ia:QLS2404 very low dose
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 low dose
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 middle dose
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 high dose
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 Max dose
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ib:QLS2404 low dose
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 middle dose
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 high dose
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Locations (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China