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

NCT07445906 | Not Yet Recruiting Phase 1

• 1 other identifier: RG002C0106-102
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Impairments; IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (6)

• Calculate the pharmacokinetic (PK) parameters:Cmax

  From enrollment to the end of treatment at 4 days

• Calculate the pharmacokinetic (PK) parameters:Tmax

  From enrollment to the end of treatment at 4 days

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

  From enrollment to the end of treatment at 4 days

• Calculate the pharmacokinetic (PK) parameters:t½

  From enrollment to the end of treatment at 4 days

• Calculate the pharmacokinetic (PK) parameters:Vd/F

  From enrollment to the end of treatment at 4 days

• Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.

  up to 169 days

Study Arms (1)

RG002C0106 Injection

EXPERIMENTAL

Drug: RG002C0106

Interventions

RG002C0106 DRUG

Subcutaneous (SC) single dose 200mg

RG002C0106 Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hongwei Tian

CONTACT

8610-63729218; hwtian@rigerna.com

Lingling Zhu

CONTACT

llzhu@rigerna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 3, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share