Actively Recruiting
A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2026-04-13
130
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase Ia: Healthy adults aged 18 to 55 years who can understand and consent to the study
- Body mass index between 19 to 32 kg/m² and weight at least 50 kg for healthy participants
- Good health status without significant abnormalities based on medical history and tests for healthy participants
- Total immunoglobulin G level above 10 g/L and normal immunoglobulin A and M levels for healthy participants
- Phase Ib & II: Adults aged 18 years or older with biopsy-confirmed IgA Nephropathy
- Body mass index of 16 kg/m² or higher for IgAN patients
- Urine protein-to-creatinine ratio of 0.5 g/g or higher or 24-hour urine protein of 0.75 g or higher before first dose
- Stable and optimized use of ACE inhibitors or angiotensin II receptor blockers; stable dose if using SGLT2 inhibitors or endothelin receptor antagonists
- Acceptable blood, liver, coagulation, and kidney function tests for IgAN patients
You will not qualify if you...
- Phase Ia: Pregnant, nursing, or planning pregnancy during the study
- Any significant disease or condition that poses safety risks or interferes with study assessments
- Immunosuppressive or immunodeficiency conditions, including HIV infection or history of severe infections
- Recent infections requiring hospitalization or treatment within 28 days before study drug administration
- Use of prescription, over-the-counter, herbal, topical, or dietary supplements within 28 days before study drug administration
- Participation in other clinical trials or investigational drug use within 3 months before study drug administration
- Receipt of antibody or biologic therapy within 28 days before study drug administration
- History of drug abuse or positive drug screening
- Phase Ib & II: Secondary IgAN or IgA vasculitis
- Chronic kidney disease from causes other than IgAN
- Significant abnormalities on kidney biopsy
- Kidney biopsy showing tubular-interstitial fibrosis over 50% or glomerular crescents over 25%
- Rapidly progressive glomerulonephritis with eGFR decline of 50% or more within 3 months prior to screening
- Nephrotic syndrome with urine protein over 3.5 g and low serum albumin
- Use of rituximab or B-cell depleting agents within 6 months prior to screening
- Low total IgG level below 6 g/L, uncontrolled type 2 diabetes, or type 1 diabetes
- Prior treatment with APRIL-targeted medications
- Recent use of biologic agents, cyclophosphamide, other immunosuppressives, or high-dose corticosteroids before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
H
Hong Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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