A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants

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.

Eligibility

Age range

18–55 years

Sex

All

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

Location