drugset / Trial / NCT07842393
A Study of IBI3042 in Healthy Adult Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IBI3042 | Unknown | — | Oral |
Indications
No indication recorded.