Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT07000292
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 to 65 years (including boundary values), gender unspecified；
2. Willing to participate voluntarily in this clinical study and with good compliance；
3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:
1. Diagnosed with lupus nephritis(LN);
2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);
4. Sufficient organ function;
Exclusion Criteria:
1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
2. Active infection requiring antibiotic treatment；
3. Concomitant with other serious diseases；
4. Patients with congenital immunoglobulin deficiency；
5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));
6. Other exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07000292
Study Brief:
Protocol Section:
NCT07000292