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This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDBH120 injection (SAD) | Experimental |
| |
| Placebo of THDBH120 injection (SAD) | Placebo Comparator |
| |
| THDBH120 injection (MAD) | Experimental |
| |
| Placebo of THDBH120 injection (MAD) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDBH120 injection (SAD) | Drug | Participants received escalating single doses of THDBH120 by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | From the first drug administration to the follow-up visit (57 days after the last drug administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120. | Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD) | |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120 | Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD) |
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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 (SAD) | Drug | Participants received single dose of placebo by subcutaneous injection. |
|
| THDBH120 injection (MAD) | Drug | Participants received multiple doses of THDBH120 once weekly for four weeks by subcutaneous injection. |
|
| Placebo of THDBH120 injection (MAD) | Drug | Participants received placebo once weekly for four weeks by subcutaneous injection. |
|
| Evaluate the Fasting Blood Glucose (FBG ) of THDBH120 | Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD) |
| Number of Participants With Anti-THBHD120 Antibodies | From the first drug administration to the follow-up visit (57 days after the last drug administration) |
| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
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