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NCT07842393
A Study of IBI3042 in Healthy Adult Participants
Conditions: Healthy Volunteers (HV)
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 32
Sponsor: Fortvita Biologics (USA)Inc.
Location: ICON Lenexa Lenexa Kansas
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 Criteria
Inclusion Criteria:
* Aged 18 to 55 years, inclusive.
* BMI ≥20 and \
Source: ClinicalTrials.gov (NCT07842393). StuddyBuddy aggregates publicly available trial information.
