A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
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.
| Condition(s) | Immunoglobulin A Nephropathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: \- Phase Ia: 1. Able to understand and voluntarily sign the written Informed Consent Form (ICF), willing and able to comply with all study requirements; 2. Healthy participants aged 18 to 55 years (inclusive) at the time of signing the ICF, of either sex; 3. Have a body mass index (BMI) between 19 to 32 kg/m² (inclusive) and a body weight ≥ 50 kg at screening; 4. Assessed to be in good health status based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests, with no clinically significant abnormalities; 5. Have a total immunoglobulin G (IgG) level \> 10 g/L at screening; and immunoglobulin A (IgA) and immunoglobulin M (IgM) levels within the normal reference ranges. Phase Ib\&II: 1. Able to understand and |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Beijing Mabworks Biotech Co., Ltd. |
| Locations | Beijing, China |
| Start date | 2026-02-05 |
| NCT ID | NCT07375758 |
| Official listing | https://clinicaltrials.gov/study/NCT07375758 |