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To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single ascending | Experimental | Drug or placebo, oral, fast, single dose ascending |
|
| multiple ascending | Experimental | Drug or placebo, oral, fast, multiple dose ascending |
|
| Food Effect | Experimental | Drug or placebo, oral, fed or fast, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC53856 | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule | Up to Day 10 after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration | Up to 96 hours after dosing |
| Cmax | Maximum observed plasma concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Vz/F | Apparent volume of distribution | Up to 96 hours after dosing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ding Yanhua, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| placebo | Drug | oral administration |
|
|
| Up to 96 hours after dosing |
| Tmax | Time of the maximum observed plasma concentration | Up to 96 hours after dosing |
| T T½ | Apparent terminal elimination half-life | Up to 96 hours after dosing |