A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants
NCT07528703 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-04-14
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
Interventions
- 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
Sponsors & Collaborators
-
Nanjing Reju Therapeutics Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-04-30
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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