Status:
COMPLETED
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
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
Eligibility Criteria
Inclusion
- Age 18-65 years, regardless of gender;
- Weight ≥45.0 kg at screening;
- Confirmed SLE diagnosis for ≥12 weeks at screening.
Exclusion
- Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
- History of alcohol abuse or illegal drug use within one year prior to screening.
- Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
- Current active infection or a history of active tuberculosis
- Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.
Key Trial Info
Start Date :
November 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06955598
Start Date
November 24 2024
End Date
November 21 2025
Last Update
December 15 2025
Active Locations (1)
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1
Renji Hospital affiliated to Shanghai Jiaotong
Shanghai, Shanghai Municipality, China, 200000