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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.
Pharmacokineticï¼›Safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 liquid formulation | Experimental | Participants received single subcutaneous injection of IBI362 liquid formulation |
|
| IBI362 lyophilized powder | Experimental | Participants received single subcutaneous injection of IBI362 lyophilized powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 liquid formulation | Drug | Administered by subcutaneous injection |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Li | The Sceond Affiliated Hospital of Nanchang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sceond Affiliated Hospital of Nanchang University | Nanchang | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| IBI362 lyophilized powder |
| Drug |
Administered by subcutaneous injection |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |