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.
Able to understand and voluntarily sign the written Informed Consent Form (ICF), willing and able to comply with all study requirements;
Healthy participants aged 18 to 55 years (inclusive) at the time of signing the ICF, of either sex;
Have a body mass index (BMI) between 19 to 32 kg/m² (inclusive) and a body weight ≥ 50 kg at screening;
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;
Nursing, lactating or pregnant, or who have plans to become pregnant during the study
History or evidence of any clinically significant disease, disorder, or condition that, in the investigator's judgment, may pose a risk to the participants' safety, interfere with the study assessments, or render the subject unsuitable for participation, including but not limited to respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurologic, cardiovascular, psychiatric, or other systemic diseases;
Any confirmed or suspected immunosuppressive or immunodeficiency condition, including human immunodeficiency virus (HIV) infection or asplenia; history of recurrent or severe infections, or long-term use of immunosuppressive agents within 6 months prior to screening;
History of chronic infection (e.g., tuberculosis, osteomyelitis) or any infectious disease requiring hospitalization or treatment with antiviral, antibiotic, or antifungal agents within 28 days prior to administration of the study drug;
Parallel
MIL116
DrugMIL116 is supplied as sterile solution for subcutaneous (SC) injection.
Matching Placebo
DrugPlacebo is to be administered at a matching volume by SC injection.
Phase Ia: Safety and Tolerability of Single Ascending Doses of MIL116 in Healthy Participants.
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Phase Ib: Safety and Tolerability of Multiple-Ascending Doses of MIL116 in IgAN Participants.
Description: Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Phase II: Change in Gd-IgA1 from Baseline at Week 12
Evaluate the degree and percentage change of Gd-IgA1 from baseline.
Change in 24-Hour Urine UPCR from Baseline at Week 24
Evaluate the degree and percentage change of 24-hour urine UPCR from baseline
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