NCT07375758

A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.

A Phase I/II, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Beijing Mabworks Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I/II study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.

Conditions

• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DRUG	MIL116	MIL116 is supplied as sterile solution for subcutaneous (SC) injection.
DRUG	Matching Placebo	Placebo is to be administered at a matching volume by SC injection.

Timeline

• Start date: 2026-02-05
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-01-29
• Last updated: 2026-04-13

Locations

1 site across 1 country: China