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This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
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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 mg-maximum tolerated dose (MTD), single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| TEAE | Incidence of Treatment Emergent Adverse Event(s) | 50 days |
| Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) | 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma drug concentration | 50 days |
| AUClast | area under the curve from 0 through the time of the last accurately measurable concentration |
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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 |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Other |
administered the same volume as GZR18 |
|
| 50 days |
| AUC0-inf | area under the curve extrapolated to infinity | 50 days |
| Tmax | time to maximum plasma drug concentration | 50 days |
| λz | elimination rate constant | 50 days |
| t1/2 | half-life | 50 days |
| tlag | lag time | 50 days |
| CL/F | apparent clearance | 50 days |
| Vz/F | volume of distribution/F | 50 days |
| AUC%extra | percent of AUC0-inf extrapolated | 50 days |
| MRT | mean residence time | 50 days |
| Weight | 50 days |
| Body Mass Index (BMI) | 50 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |