NCT06494527

A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults

A Randomized, Double-blind, Placebo-controlled, Single/Multiple Ascending Dose, Phase 1 International Multi-center Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of RG002C0106 Injection in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts: Part A, conducted : SAD stage Part B, conducted: MAD stage

Detailed description

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts: Part A, conducted : SAD stage Part B, conducted: MAD stage There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg，and the highest dose will be mainly determined based on the data obtained during the study process. There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	RG002C0106	RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit the expression of C3 protein.

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-08-20
• Completion: 2026-08-20
• First posted: 2024-07-10
• Last updated: 2026-03-03

Locations

1 site across 1 country: China