A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants
Fortvita Biologics (USA)Inc.
Summary
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- DrugIBI3032
IBI3032: Method of administration: oral, fasted administration.
- Drugplacebo
Placebo (without active ingredients) Method of administration: oral, fasted administration.
Location
- ICON Clinical ResearchLenexa, Kansas