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This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study.
The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR18 injection、[14C]GZR18 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR18 injection、[14C]GZR18 injection | Drug | Participants will get a single dose of [14C]GZR18 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces). | Through study completion, an average of 1 year |
| Primary Outcome Measure | Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces. | Through study completion, an average of 1 year |
| Primary Outcome Measure | Peak Plasma Concentration (Cmax) | Through study completion, an average of 1 year |
| Primary Outcome Measure | Area under the plasma concentration versus time curve (AUC) | Through study completion, an average of 1 year |
| Primary Outcome Measure | Ratio of total radioactivity concentration in whole blood to plasma | Through study completion, an average of 1 year |
| Primary Outcome Measure | Time-To-Peak(Tmax) | Through study completion, an average of 1 year |
| Primary Outcome Measure | Mean Residence Time | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of GZR18 and its metabolites (if applicable) in plasma | Peak Plasma Concentration (Cmax) | Through study completion, an average of 1 year |
| Safety Evaluation:Clinical safety evaluation during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study site 01 | Beijing | 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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| Primary Outcome Measure | Half-Life Period(T1/2) | Through study completion, an average of 1 year |
weight and height will be combined to report BMI in kg/m^2
| Average of 1 year |
| PK parameters of GZR18 and its metabolites (if applicable) in plasma | Area under the plasma concentration versus time curve (AUC) | Through study completion, an average of 1 year |
| PK parameters of GZR18 and its metabolites (if applicable) in plasma | Time-To-Peak(Tmax) | through study completion, an average of 1 year |
| PK parameters of GZR18 and its metabolites (if applicable) in plasma | Mean Residence Time | through study completion, an average of 1 year |
| PK parameters of GZR18 and its metabolites (if applicable) in plasma | Half-Life Period(T1/2) | through study completion, an average of 1 year |
| Safety Evaluation:Clinical safety evaluation during the study | laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, stool analysis + occult blood and thyroid function) | Average of 1 year |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |