Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR4 | Experimental | s.c, single dose |
|
| Placebo | Placebo Comparator | s.c, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR4 | Drug | Ascending single doses - 4 dose levels. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAE | Baseline to Day29 |
| Measure | Description | Time Frame |
|---|---|---|
| GIRmax | Day2-Day3 | |
| Tmax,GIR | Day2-Day3 | |
| AUCGIR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals Co., Ltd | Beijing | Beijing Municipality | 100000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Ascending single doses - 4 dose levels. |
|
| Day2-Day3/Day7-Day8 |
| Cmax | Baseline to Day29 |
| Tmax,GZR4 | Baseline to Day29 |
| T1/2 | Baseline to Day29 |
| AUC0-inf | Baseline to Day29 |
| AUC0-last | Baseline to Day29 |