A PhaseⅠ Study of HW252001 in Healthy Subjects

Sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study ID
NCT07493031
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HW252001 — DRUG
    HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
  • Placebo — DRUG
    Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

Study Details

This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

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

Arms

  • Experimental: HW252001
    Single or multiple oral dose of HW252001
  • Placebo Comparator: Placebo
    Single or multiple oral dose of placebo

Primary Outcome Measure

The number and severity of treatment emergent adverse events (TEAEs) [ Time Frame: up to 11 days ]

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