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

NCT07375758 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Mabworks Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2028-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07375758 on ClinicalTrials.gov