A Study of IBI3042 in Healthy Adult Participants
ConditionHealthy Volunteers (HV)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFortvita Biologics (USA)Inc.
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 55 years, inclusive.
BMI ≥20 and <32 kg/m² and body weight ≥50 kg;
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.
Able and willing to comply with study procedures and voluntarily provide written informed consent.
Disqualifiers
Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
History of diabetes or abnormal glycemic parameters at screening.
Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
Trial design
Design model
Sequential
Treatments tested in this trial
Investigational Drug: IBI3042
DrugOral, corresponding dose regimen according to study cohort
Matching Placebo
DrugOral, matching to IBI3042, corresponding dose regimen according to study cohort
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Matching PlaceboPlacebo comparator 1 intervention
Group B: Investigational Drug: IBI3042Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events
Number of Participants With Adverse Events.
Time frame
through study completion, an average of 29 days2
Number of Participants With Clinically Significant Abnormal Vital Signs
Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame
through study completion, an average of 29 days3
Number of Participants With Clinically Significant Abnormal 12-lead electrocardiogram
Number of participants with at least one clinically significant abnormal finding on resting 12-lead electrocardiogram(ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECGrecording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF(QTcF=QT/RR\^0.33).
Time frame
through study completion, an average of 29 days4
Number of Participants With Abnormal General Appearance Findings
Number of participants with at least one clinically significant abnormal finding in general appearance on physical examination.
Time frame
through study completion, an average of 29 daysSecondary outcomes
1
Area Under the Plasma Concentration Time Curve (AUC)
Time frame
through study completion, an average of 29 days2
Peak Plasma Concentration (Cmax)
Time frame
through study completion, an average of 29 days3
Time to Reach Peak Plasma Concentration (Tmax)
Time frame
through study completion, an average of 29 days4
Apparent Clearance (CL/F)
Time frame
through study completion, an average of 29 daysSponsors and contacts
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Source ClinicalTrials.gov
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