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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy (IgAN); Renal Impairments
• Intervention / Treatment: Drug: RG002C0106

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hongwei Tian; Phone Number: 8610-63729218; Email: hwtian@rigerna.com
• Study Contact Backup: Name: Lingling Zhu; Email: llzhu@rigerna.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Have been fully informed about the study, volunteered to participate, and provided written informed consent.
2. Male or female participants aged 18-60 years (inclusive) at screening.
3. 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.

4. 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.

5. 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:

1. At screening, chest radiography demonstrates clinically significant abnormalities.

2. 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.

3. Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.
4. 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).
5. 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.
6. Presence or suspected presence of other active viral, bacterial, fungal, or parasitic infections within 4 weeks before screening.
7. History of epidemic meningococcal infection, or other recurrent or chronic infections.
8. History of splenectomy or asplenia.
9. History of complement abnormalities or hereditary complement deficiency.
10. Development of acute kidney injury within 2 weeks before screening.
11. History of renal transplantation, or requirement for renal dialysis during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RG002C0106 Injection	Drug: RG002C0106; Subcutaneous (SC) single dose 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.	up to 169 days
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: RG002C0106-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No