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A Study of IBI3042 in Healthy Adult Participants
Sponsor: Fortvita Biologics (USA)Inc.
Summary
This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-09-29
Completion Date
2027-02-03
Last Updated
2026-09-25
Healthy Volunteers
Yes
Conditions
Interventions
Investigational Drug: IBI3042
Oral, corresponding dose regimen according to study cohort
Matching Placebo
Oral, matching to IBI3042, corresponding dose regimen according to study cohort
Locations (1)
ICON Lenexa
Lenexa, Kansas, United States