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IBI3042 for Healthy Volunteers

DL
Overseen ByDee Li
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Fortvita Biologics (USA)Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants must meet health requirements set by the study and cannot join if they have certain illnesses or risk factors.

Inclusion Criteria

Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose
BMI ≥20 and <32 kg/m² and body weight ≥50 kg
Able and willing to comply with study procedures and voluntarily provide written informed consent
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Exclusion Criteria

Clinically significant abnormalities in physical examination or laboratory tests at screening
Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable
Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study
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What Are the Treatments Tested in This Trial?

Interventions

  • IBI3042

Trial Overview

The study tests different single oral doses of a new drug called IBI3042 compared to a placebo in healthy adults. It uses random assignment, blinding, and gradually increases the dose to check safety and how the body processes the drug.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational Drug: IBI3042Experimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention

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Who Is Running the Clinical Trial?

Fortvita Biologics (USA)Inc.

Lead Sponsor

Trials
1
Recruited
80+

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