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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.