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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
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This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZT002 | Experimental | Participants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive ZT002 injection or Placebo in 1 of 6 dose cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZT002 | Drug | Participants will receive a single subcutaneous (SC) ZT002 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events | Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA). | Up to 50 days |
| Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events. | Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA). | Up to 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts. | Parameter: Maximum observed plasma concentration of ZT002 (Cmax) | Up to 50 days |
| The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aixin Shi, Master | No.1 Dahua Road, Dongdan, Dongcheng District, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Other |
Participants will receive same volume as of the study drug. |
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Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last) |
| Up to 50 days |
| The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD cohorts. | Parameter: Area under the drug-time curve to infinity (AUC0-inf) | Up to 50 days |
| D004700 | Endocrine System Diseases |