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NOT YET RECRUITING
NCT07751315
PHASE1

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

Ia:QLS2404 very low dose

a single subcutaneous dose of QLS2404 Injection in healthy participants

DRUG

Ia:QLS2404 low dose

a single subcutaneous dose of QLS2404 Injection in healthy participants

DRUG

Ia:QLS2404 middle dose

a single subcutaneous dose of QLS2404 Injection in healthy participants

DRUG

Ia:QLS2404 high dose

a single subcutaneous dose of QLS2404 Injection in healthy participants

DRUG

Ia:QLS2404 Max dose

a single subcutaneous dose of QLS2404 Injection in healthy participants

DRUG

Ib:QLS2404 low dose

multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)

DRUG

Ib:QLS2404 middle dose

multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)

DRUG

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