A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.0 个研究点目标入组 24 人开始时间: 2026年3月15日最近更新: 2026年3月3日

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 24
主要终点: Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.
•Absolute estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI 2021 equation during the screening period, falls into the corresponding group as follows:
•Normal renal function: absolute eGFR ≥ 90 mL/min; Mild renal impairment: 60 mL/min ≤ absolute eGFR < 90 mL/min; Moderate renal impairment: 30 mL/min ≤ absolute eGFR < 60 mL/min.
•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.

排除标准

•At screening, chest radiography demonstrates clinically significant abnormalities.
•Any of the following abnormal laboratory test results at screening:
•Total bilirubin > 1.5 × upper limit of normal (ULN); ALT or AST > 2 × ULN; International normalized ratio (INR) > 2 or any clinically significant abnormality; QTcF ≥ 450 ms in males or QTcF ≥ 470 ms in females (QTc interval must be heart rate-corrected using the Fridericia formula); Other abnormal laboratory test results deemed clinically significant by the investigator.
•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.
•Presence or suspected presence of other active viral, bacterial, fungal, or parasitic infections within 4 weeks before screening.
•History of epidemic meningococcal infection, or other recurrent or chronic infections.
•History of splenectomy or asplenia.
•History of complement abnormalities or hereditary complement deficiency.
•Development of acute kidney injury within 2 weeks before screening.
•History of renal transplantation, or requirement for renal dialysis during the study.

研究组 & 干预措施

RG002C0106 Injection

Experimental

干预措施: RG002C0106 (Drug)