A Study of IBI3032 in Healthy Participants

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Fortvita Biologics (USA)Inc.
Study ID
NCT07120425
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • IBI3032 — DRUG
    IBI3032: Method of administration: oral, fasted administration.
  • placebo — DRUG
    Placebo (without active ingredients) Method of administration: oral, fasted administration.

Study Details

This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. This study is for research purposes only, and is not intended to treat any medical condition.

Key Dates

Start date
Sep 10, 2025
Status verified
Sep 2025
Primary completion
Nov 13, 2025
Completion
Nov 13, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Single dose4 of IBI3032 administered orally.
    dose4 IBI3032
  • Experimental: Single dose3 of IBI3032 administered orally.
    dose3 IBI3032
  • Placebo Comparator: Single dose4 of placebo administered orally.
    dose4 placebo
  • Experimental: Single dose1 of IBI3032 administered orally.
    dose1 IBI3032
  • Placebo Comparator: Single dose3 of placebo administered orally.
    dose3 placebo
  • Placebo Comparator: Single dose1 of placebo administered orally.
    dose1 placebo
  • Experimental: Single dose2 of IBI3032 administered orally.
    dose2 IBI3032
  • Placebo Comparator: Single dose2 of placebo administered orally.
    dose2 placebo

Primary Outcome Measure

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug [ Time Frame: Baseline up to Day 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Clinical ResearchLenexaKansas66219
Seth Price
[email protected]
913-205-4397

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ICON Clinical Research· Lenexa, KS

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