A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Mode… (NCT07445906) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
24 participantsStarted 2026-03-15
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. At screening, chest radiography demonstrates clinically significant abnormalities.
✕. Any of the following abnormal laboratory test results at screening:
✕. 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.
What they're measuring
1
Calculate the pharmacokinetic (PK) parameters:Cmax
Timeframe: From enrollment to the end of treatment at 4 days
2
Calculate the pharmacokinetic (PK) parameters:Tmax
Timeframe: From enrollment to the end of treatment at 4 days
3
Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞
Timeframe: From enrollment to the end of treatment at 4 days
4
Calculate the pharmacokinetic (PK) parameters:t½
Timeframe: From enrollment to the end of treatment at 4 days
5
Calculate the pharmacokinetic (PK) parameters:Vd/F
Timeframe: From enrollment to the end of treatment at 4 days
6
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.