NCT06955598CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 8 Apr 2025
- Start date
- 24 Nov 2024
- Primary completion date
- 10 Nov 2025
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Lupus (SLE)
- NCT number
- NCT06955598
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 24 Nov 2024 to the primary completion date, 10 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
Who the study is looking for
- Age 18-65 years, regardless of gender;
- Weight ≥45.0 kg at screening;
- Confirmed SLE diagnosis for ≥12 weeks at screening.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital affiliated to Shanghai Jiaotong Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.