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

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.

Conditions

• Systemic Lupus Erythematosus
• Primary Sjögren's Syndrome

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)

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Ping Feng, phD · West China Hospital

• Qibing Xie, phD · West China Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-11

Primary Completion

2027-11-07

Completion

2028-06-30

Countries

• China

Study Locations