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This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD in healthy subjects-Cohort 1 | Experimental | SAD cohort 1, dose 1 |
|
| SAD in healthy subjects-Cohort 2 | Experimental | SAD Cohort 2, dose 2 |
|
| SAD in healthy subjects-Cohort 3 | Experimental | SAD Cohort 3, dose 3 |
|
| SAD in patients with obesity-Cohort 3A | Experimental | SAD Cohort 3A, dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC47 | Drug | single subcutaneous injection of ASC47 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days. | up to 57 days |
| ECG QT Interval | Evaluate the ECG QT Interval after single doses of ASC47. | up to 57 days |
| Blood cell | Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47. | up to 57 days |
| Hematology | Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47. | up to 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ASC47 | Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47. | up to 57 days |
| Cmax of ASC47 | Evaluate the Peak Plasma Concentration after single doses of ASC47. |
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Key inclusion Criteria:
Key exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis | Herston | Queensland | 4006 | Australia |
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| Matching placebo | Drug | single subcutaneous injection of Placebo |
|
| up to 57 days |
| Cmin of ASC47 | Evaluate the Minimum Plasma Concentration after single doses of ASC47. | up to 57 days |
| T1/2 of ASC47 | Evaluate the Terminal-Phase Half-Life after single doses of ASC47 | up to 57 days |
| CL/F of ASC47 | Evaluate the Apparent Systemic Clearance after single doses of ASC47. | up to 57 days |
| Vd/F of ASC47 | Evaluate the Apparent Volume of Distribution after single doses of ASC47. | up to 57 days |
| Lipid parameters | Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47. | up to 57 days |