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

December 11, 2025 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Renji Hospital affiliated to Shanghai Jiaotong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A:
SHR-2173 injection dose 1
Drug: SHR-2173
SHR-2173
Experimental: Treatment group B:
SHR-2173 injection dose 2
Drug: SHR-2173
SHR-2173
Experimental: Treatment group C:
SHR-2173 injection dose 3
Drug: SHR-2173
SHR-2173

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Week 0~16
Week 0~16

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax,
Time Frame: Week 0~16
Week 0~16
AUC0-t,
Time Frame: Week 0~16
Week 0~16
Anti- SHR -2173 antibody (ADA)
Time Frame: Week 0~16
Week 0~16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Actual)

November 10, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-2173-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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