NCT07528703

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants

A Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Chinese Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Nanjing Reju Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of RC010 in healthy adult volunteers. RC010 is a small-molecule drug , being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability and pharmacokinetics of RC010 after Single ascending doses .

Conditions

• IPF

Interventions

Type	Name	Description
DRUG	RC010 Inhalation Powder	Participants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups
DRUG	RC010 Inhalation Powder placebo	Match to RC010 Inhalation Powder dose groups

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study