A Study of IBI3032 in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFortvita Biologics (USA)Inc.
About this trial
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study.
The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. This study is for research purposes only, and is not intended to treat any medical condition.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male or females, as determined by medical history
Have safety laboratory results within normal reference ranges
Disqualifiers
Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
Abnormal electrocardiogram (ECG) at screening
Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
Trial design
Design model
Sequential
Treatments tested in this trial
IBI3032
DrugIBI3032: Method of administration: oral, fasted administration.
placebo
DrugPlacebo (without active ingredients) Method of administration: oral, fasted administration.
Treatment groups
32 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Single dose4 of IBI3032 administered orally.Experimental treatment 1 intervention
Group B: Single dose3 of IBI3032 administered orally.Experimental treatment 1 intervention
Group C: Single dose4 of placebo administered orally.Placebo comparator 1 intervention
Group D: Single dose1 of IBI3032 administered orally.Experimental treatment 1 intervention
Group E: Single dose3 of placebo administered orally.Placebo comparator 1 intervention
Group F: Single dose1 of placebo administered orally.Placebo comparator 1 intervention
Group G: Single dose2 of IBI3032 administered orally.Experimental treatment 1 intervention
Group H: Single dose2 of placebo administered orally.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame
Baseline up to Day 152
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame
Baseline up to Day 153
Number of Participants with adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Time frame
Baseline up to Day 15Secondary outcomes
1
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Time frame
Predose up to 168 hours postdose2
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Time frame
Predose up to 168 hours postdose3
time to maximum concentration (Tmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Time frame
Predose up to 168 hours postdose4
clearance (CL) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Time frame
Predose up to 168 hours postdoseSponsors and contacts
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Source ClinicalTrials.gov