A Phase Ia Clinical Trial of HW241045

Sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study ID
NCT07448194
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers
  • IPF

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HW241045 — DRUG
    Dose 1 to Dose 7
  • Placebo — DRUG
    Dose 1 to Dose 7

Study Details

This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.

Key Dates

Start date
Nov 24, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: HW241045
    Single oral dose of HW241045
  • Placebo Comparator: Placebo
    Single oral dose of Placebo

Primary Outcome Measure

The number and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 48 hours ]

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