IgA Nephropathy Clinical Trials

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⁃ Phase Ia:

• 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;

• 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:

• Able to understand and voluntarily sign the written ICF, and willing and able to comply with all study requirements;

• Aged ≥ 18 years at the time of signing the ICF, of either sex, with a BMI ≥ 16 kg/m²;

• Biopsy-confirmed diagnosis of IgA Nephropathy (IgAN). Participants must have a 24-hour urine protein-to-creatinine ratio (UPCR) ≥ 0.5 g/g or 24-hour urine protein ≥ 0.75 g prior to the first dose;

• Have been receiving an optimized and stable dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB). If currently receiving sodium-glucose cotransporter 2 inhibitors (SGLT2i) and / or endothelin receptor antagonists (ERA), the same administration and dose stability requirements apply for;

• Have acceptable hematologic, hepatic, coagulation, and renal function as assessed by clinical laboratory tests.