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

Sponsor
Nanjing Reju Therapeutics Co., Ltd
Study ID
NCT07528703
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 .

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RC010 Inhalation Powder
    RC010 Inhalation Powder：01.mg、0.3mg、0.75mg、1.5mg and 2mg，Single-dose administration
  • Experimental: RC010 Inhalation Powder placebo
    RC010 Inhalation Powder placebo：0mg，Single-dose administration

Primary Outcome Measure

The incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Day1-Day14 ]

Central Contacts

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