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

NCT06955598 | Completed Phase 1

• 1 other identifier: SHR-2173-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Week 0~16

Secondary Outcomes (3)

• Cmax,

  Week 0~16

• AUC0-t,

  Week 0~16

• Anti- SHR -2173 antibody (ADA)

  Week 0~16

Study Arms (3)

Treatment group A:

EXPERIMENTAL

SHR-2173 injection dose 1

Drug: SHR-2173

Treatment group B:

EXPERIMENTAL

SHR-2173 injection dose 2

Drug: SHR-2173

Treatment group C:

EXPERIMENTAL

SHR-2173 injection dose 3

Drug: SHR-2173

Interventions

SHR-2173 DRUG

SHR-2173

Treatment group A:; Treatment group B:; Treatment group C:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Renji Hospital affiliated to Shanghai Jiaotong

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 2, 2025
• Study Start: November 24, 2024
• Primary Completion: November 10, 2025
• Study Completion: November 21, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-04

Locations

CN (1)