This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.
Have been fully informed about the study, volunteered to participate, and provided written informed consent.
Male or female participants aged 18-60 years (inclusive) at screening.
Body mass index (BMI) of 19.0-32.0 kg/m² (inclusive) at screening; body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants.
Female participants of childbearing potential must have a negative serum pregnancy test during the screening period. Highly effective contraception must be used from signing the informed consent form until 6 months after the last dose of the study drug, by the participant and their partner of childbearing potential.
At screening, chest radiography demonstrates clinically significant abnormalities.
Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.
Participants with primary or secondary IgA nephropathy (patients with IgA nephropathy are advised to be screened for the Phase IIa study of the investigational product).
Current diagnosis of tuberculosis (TB); history of active TB with cure < 5 years prior to screening; or high likelihood of TB infection as judged by the investigator based on comprehensive TB screening during the screening period.