Skip to main content
OpenTrials
Completed

NCT Number: NCT06955598

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

To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Renji Hospital affiliated to Shanghai Jiaotong

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

SHR-2173

Drug

SHR-2173

Primary outcomes

  1. Adverse events

    Time frame: Week 0~16

Secondary outcomes

  1. Cmax,

    Time frame: Week 0~16

  2. AUC0-t,

    Time frame: Week 0~16

  3. Anti- SHR -2173 antibody (ADA)

    Time frame: Week 0~16

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.