Evaluating a new treatment for systemic lupus erythematosus
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
This study is testing a new treatment called SHR-2173 to see if it is safe and effective for people with systemic lupus erythematosus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06955598 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2173, administered through multiple subcutaneous injections, in patients diagnosed with systemic lupus erythematosus (SLE). The study will involve participants aged 18 to 65 who have had a confirmed diagnosis of SLE for at least 12 weeks. By closely monitoring the effects of the treatment, researchers hope to gather valuable data on how SHR-2173 interacts with the body and its potential therapeutic benefits for SLE patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a confirmed diagnosis of systemic lupus erythematosus for at least 12 weeks.
Not a fit: Patients with other inflammatory or autoimmune diseases that may interfere with the study results will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic lupus erythematosus.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in the treatment of autoimmune diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Renji Hospital affiliated to Shanghai Jiaotong — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Zhe Zhang
- Email: zhe.zhang@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.