Actively Recruiting
A Phase I/II, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying MIL116, an anti-APRIL monoclonal antibody, to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy adults and patients with Immunoglobulin A Nephropathy (IgAN). This Phase I/II clinical trial aims to understand how the drug behaves in the body and its effects in these populations. Participants will receive either MIL116 or a matching placebo through subcutaneous injections. The study includes a single ascending dose phase for healthy participants and multiple ascending dose phases for patients with IgAN. The trial involves randomized assignment to either the experimental drug or placebo group with quadruple masking to reduce bias. During the study, participants will undergo regular health assessments including medical exams, vital signs, electrocardiograms, and laboratory tests. Researchers will monitor safety and tolerability up to 6 months in healthy volunteers and up to 18 months in IgAN patients. Key outcomes measured include changes in specific protein markers related to IgAN and urine protein levels over 12 to 24 weeks. Total participation duration varies depending on the study phase.
CONDITIONS
Brief Title
A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the written Informed Consent Form and comply with study requirements
- Healthy participants aged 18 to 55 years, of either sex
- Body mass index (BMI) between 19 to 32 kg/m² and body weight ≥ 50 kg at screening
- Good health status based on medical history, physical exam, vital signs, ECG, and lab tests with no significant abnormalities
- Total immunoglobulin G (IgG) level > 10 g/L and normal IgA and IgM levels at screening
- For patients: aged ≥ 18 years, of either sex, with BMI ≥ 16 kg/m²
- Biopsy-confirmed diagnosis of IgA Nephropathy with specific urine protein levels
- Receiving optimized and stable doses of ACE inhibitors or ARBs, with similar stability for SGLT2i or ERA if applicable
- Acceptable hematologic, hepatic, coagulation, and renal function by lab tests
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study
- Significant diseases or conditions that may pose safety risks or interfere with the study
- Immunosuppressive or immunodeficiency conditions, including HIV infection or asplenia
- Recent infections or long-term use of immunosuppressive agents
- Use of prescription, OTC, herbal, topical products, or supplements within specified timeframes before dosing
- Participation in other investigational drug or device studies within 3 months or relevant drug half-lives
- Prior treatment with investigational antibodies or biologics recently
- History of drug abuse or positive drug screening
- Secondary IgAN or IgA vasculitis
- Other causes of chronic kidney disease or significant kidney biopsy abnormalities
- Rapidly progressive glomerulonephritis or nephrotic syndrome
- Recent use of rituximab, B-cell depleting agents, or biologic therapies
- Low IgG levels, uncontrolled diabetes, or type 1 diabetes
- Prior APRIL-targeted treatments
- Recent immunosuppressive or corticosteroid therapies exceeding specified doses and durations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive MIL116 or placebo by subcutaneous injection to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits for dosing and assessments during treatment period
Duration - Up to 6 months after treatment
Participants are monitored for safety and changes in clinical outcomes after treatment completion.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
H
Hong Zhang, Doctor
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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