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

ConditionsRenal ImpairmentsIgA Nephropathy (IgAN)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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.

Disqualifiers

At screening, chest radiography demonstrates clinically significant abnormalities.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • RG002C0106

    Drug

    Subcutaneous (SC) single dose 200mg

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: RG002C0106 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Calculate the pharmacokinetic (PK) parameters:Cmax

Time frame
From enrollment to the end of treatment at 4 days
2

Calculate the pharmacokinetic (PK) parameters:Tmax

Time frame
From enrollment to the end of treatment at 4 days
3

Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞

Time frame
From enrollment to the end of treatment at 4 days
4

Calculate the pharmacokinetic (PK) parameters:t½

Time frame
From enrollment to the end of treatment at 4 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: