NCT07000292

MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.

Detailed description

The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN). The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).

Conditions

• Lupus Nephritis (LN)
• ANCA-Associated Glomerulonephritis

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-05-20
• Completion: 2027-02-20
• First posted: 2025-06-02
• Last updated: 2025-06-11

Locations

1 site across 1 country: China