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A Study of IBI3032 in Healthy Participants
Sponsor: Fortvita Biologics (USA)Inc.
Summary
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.
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-09-10
Completion Date
2025-11-13
Last Updated
2025-09-17
Healthy Volunteers
Yes
Conditions
Interventions
IBI3032
IBI3032: Method of administration: oral, fasted administration.
placebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.
Locations (1)
ICON Clinical Research
Lenexa, Kansas, United States