Clinical Study of IBI362 in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

Detailed Description
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Pharmacokinetic；Safety

Official Title
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Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects

Conditions
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Overweight/Obesity

Intervention / Treatment
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* Drug: IBI362 liquid formulation
* Drug: IBI362 lyophilized powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years old≤ Healthy males≤45 years old 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m² Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: Subjects who have previously completed or discontinued from this study, or who have used IBI362. Abnormal vital signs and physical examination during the screening period; Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation. Have a previous or current mental illness. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2. There are other factors judged by the investigators that are not suitable for inclusion in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI362 liquid formulation<br>Participants received single subcutaneous injection of IBI362 liquid formulation | Drug: IBI362 liquid formulation<br>* Administered by subcutaneous injection<br>|
| Experimental: IBI362 lyophilized powder<br>Participants received single subcutaneous injection of IBI362 lyophilized powder | Drug: IBI362 lyophilized powder<br>* Administered by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the PK parameters of IBI362 in healthy Chinese male subjects | Peak Plasma Concentration (Cmax) | From the first dose of study drug until 8 weeks | 
| Evaluate the PK parameters of IBI362 in healthy Chinese male subjects | Area under the plasma concentration versus time curve (AUC) | From the first dose of study drug until 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | The relationship of each adverse event to the investigational product was assessed by the investigator. | From the first dose of study drug until 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pharmacokinetic