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This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20094 (Single dose) | Experimental | Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants. |
|
| HS-20094 (Multiple doses) | Experimental | Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants. |
|
| Placebo (Single dose) | Placebo Comparator | Placebo administered SC once in healthy participants. |
|
| Placebo (Multiple doses) | Placebo Comparator | Placebo administered SC once weekly for four weeks in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 | Drug | Administrated SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug | A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module | Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Cmax of HS-20094 | PK: Cmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimin Cui, PhD | Contact | 66110802 | 010 | cuiymzy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yimin Cui | Beijing University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University First Hospital | Recruiting | Beijing | Beijing Municipality | 110000 | 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 | Drug | Administrated SC |
|
|
PK: AUC of HS-20094
| Baseline to Day 22 (SAD) or Day 43 (MAD) |
| Pharmacokinetics (PK): Tmax of HS-20094 | PK: Tmax of HS-20094 | Baseline to Day 22 (SAD) or Day 43 (MAD) |
| Pharmacodynamics (PD): AUC of glucose | PD: AUC of glucose | Day 22 (MAD) |
| Pharmacodynamics (PD): AUC of insulin | PD: AUC of insulin | Day 22 (MAD) |
| Weight change | baseline to Day 29 (SAD) or Day 50 (MAD) |
| D004700 | Endocrine System Diseases |