Phase III Study of MIL116 Injection Evaluating Safety and Effects in Healthy Adults and Patients With IgA Nephropathy

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 III 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.

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