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This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR18 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR18 | Drug | 5 μg/kg-maximum tolerated dose (MTD), single dose or two doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TEAE | Incidence of treatment-emergent adverse events (TEAE) | after 28/35 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The peak concentration after reaching the target dose | 28/35 days |
| AUClast | the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyuan Zhao, Ph.D | Gan & Lee Pharmaceuticals. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals Co., Ltd | Beijing | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Other |
administered the same volume as GZR18 |
|
| 28/35 days |
| AUC0-inf | the area under the concentration-time curve from 0 to infinity | 28/35 days |
| Tmax | the peak time | 28/35 days |
| λz | the elimination rate constant | 28/35 days |
| t1/2 | the half-life | 28/35 days |
| tlag | retention time | 28/35 days |
| CL/F | apparent clearance rate | 28/35 days |
| Vz/F | apparent volume of distribution | 28/35 days |
| AUC%extra | extrapolation percentage of AUC0-in | 28/35 days |
| MRT | average retention time | 28/35 days |
| AUCglucose0-14h | area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration | 28/35 days |
| AUCc-peptide0-14h | area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration | 28/35 days |
| AUCinsulin0-14h | area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration | 28/35 days |
| body weight | 28/35 days |
| body mass index (BMI) | 28/35 days |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |