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The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDBH120 injection | Experimental |
| |
| Placebo of THDBH120 injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDBH120 injection | Drug | Participants received THDBH120 by subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | 78 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120. | Day 1 Pre-dose through Day 43 | |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120 | Day 1 Pre-dose through Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| Placebo of THDBH120 injection |
| Drug |
Participants received placebo by subcutaneous injection. |
|
| Change From Baseline in HbA1C | 43 days |
| Number of Participants With Anti-THBHD120 Antibodies | 78 days |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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