A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
Starting soon · Phase 1
Conditions studied: Renal Impairments, IgA Nephropathy (IgAN)
In brief
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.
Key facts
- Study ID
- NCT07445906
- Run by
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- People needed
- 24
- Starts
- 2026-03-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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