ICON Clinical Research
Lenexa, Kansas, 66219, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07120425
A Study of IBI3032 in Healthy Participants
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Exclusion criteria
- 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.
Treatment and study plan
IBI3032
DrugIBI3032:
Method of administration: oral, fasted administration.
Placebo
DrugPlacebo (without active ingredients) Method of administration: oral, fasted administration.
Primary outcomes
-
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
Time frame: Baseline up to Day 15
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
-
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time frame: Baseline up to Day 15
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
-
Number of Participants with adverse events (AEs)
Time frame: Baseline up to Day 15
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.
Secondary outcomes
-
Under the Serum Concentration-time Curve (AUC) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
-
maximum concentration (Cmax) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
-
time to maximum concentration (Tmax) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
-
clearance (CL) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
-
apparent volume of distribution (V) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
-
elimination half-life (T1/2) of IBI3032
Time frame: Predose up to 168 hours postdose
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fortvita Biologics (USA)Inc.
Industry
Registry information
Official study title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 13, 2025
- Registry last updated
- Sep 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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