A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

Korábbi kezelés

• 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.
• Development of acute kidney injury within 2 weeks before screening.

Más betegség

• Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at 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.
• History of renal transplantation, or requirement for renal dialysis during the study.

Laborértékek

• 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.

Egyéb

• At screening, chest radiography demonstrates clinically significant abnormalities.

• 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.