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
Sponsor study identifier
interventional
64
1 country
1
Study Start
August 11, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 23, 2026
Actual (reported)August 7, 2026
Actual (reported)August 11, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants
Number of participants with Adverse events and Serious adverse events
from the first single subcutaneous Inject of QLS2404 up to Day85
Ib:To evaluate the Adverse events of multiple subcutaneous injections of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS).
Number of participants with Adverse events and Serious adverse events
from the first single subcutaneous Inject of QLS2404 up to Day141.
Ia Outcome 1:To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
from the first single subcutaneous Inject of QLS2404 up to Day85
Ia Outcome 2:To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
from the first single subcutaneous Inject of QLS2404 up to Day85.
Ia Outcome 3:To evaluate the immunogenicity of a single subcutaneous injection of QLS2404 Injection in healthy participants.
from the first single subcutaneous Inject of QLS2404 up to Day85
Ib Outcome 1:Applicable to participants with SLE: The proportion of participants with a ≥ 4-point decrease from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K).
from the first subcutaneous Inject of QLS2404 up to Day141.
Ib Outcome 2:To evaluate the pharmacokinetic (PK) characteristics of multiple subcutaneous injections of QLS2404 Injection in participants .
from the first subcutaneous Inject of QLS2404 up to Day141
a single subcutaneous dose of QLS2404 Injection in healthy participants
a single subcutaneous dose of QLS2404 Injection in healthy participants
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Ping Feng, phD
West China Hospital
Qibing Xie, phD
West China Hospital
First Submitted
July 23, 2026
First Posted
August 7, 2026
Study Start
August 11, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 7, 2027
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
a single subcutaneous dose of QLS2404 Injection in healthy participants
a single subcutaneous dose of QLS2404 Injection in healthy participants
a single subcutaneous dose of QLS2404 Injection in healthy participants
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 7, 2026
Record last verified: 2026-07
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