Injection of MSC303: Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.
Study summary
This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR) — 12 week Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases.
Phase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.