drugset / Trial / NCT07842393

A Study of IBI3042 in Healthy Adult Participants

NCT07842393 ↗

Phase 1 Not yet recruiting 32 enrolled Fortvita Biologics (USA)Inc.
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2026-09-29
Primary completion
2027-02-03
Completion
2027-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI3042 Unknown — Oral

Indications

No indication recorded.