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

Phase 1

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: SHR-2173

• Registration Number: NCT06955598
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-24
• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age 18-65 years, regardless of gender;
2. Weight ≥45.0 kg at screening;
3. Confirmed SLE diagnosis for ≥12 weeks at screening.

Exclusion Criteria

1. Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
2. History of alcohol abuse or illegal drug use within one year prior to screening.
3. Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
4. Current active infection or a history of active tuberculosis
5. Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group A:	SHR-2173	SHR-2173 injection dose 1
Treatment group B:	SHR-2173	SHR-2173 injection dose 2
Treatment group C:	SHR-2173	SHR-2173 injection dose 3

Primary Outcome Measures

Name	Time	Method
Adverse events	Week 0~16

Secondary Outcome Measures

Name	Time	Method
Cmax,	Week 0~16
AUC0-t,	Week 0~16
Anti- SHR -2173 antibody (ADA)	Week 0~16

Trial Locations

Locations (1)

Renji Hospital affiliated to Shanghai Jiaotong; 🇨🇳 Shanghai, Shanghai, China