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NOT YET RECRUITING
NCT07842393
PHASE1

A Study of IBI3042 in Healthy Adult Participants

Sponsor: Fortvita Biologics (USA)Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Investigational Drug: IBI3042

Oral, corresponding dose regimen according to study cohort

DRUG

Matching Placebo

Oral, matching to IBI3042, corresponding dose regimen according to study cohort

Locations (1)

ICON Lenexa

Lenexa, Kansas, United States