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| Name | Class |
|---|---|
| Veritus Research Pty Ltd | UNKNOWN |
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This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK56630 | Drug | Orally administered tablets of HSK56630 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single ascending doses of HSK56630 in healthy adult subjects | Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0 | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants. | Peak plasma Concentration (Cmax) | 8 days |
| To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Meixia | Contact | 028-67258779 | chenmeixia@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research Pty Ltd | Recruiting | Bayswater | Victoria | 3153 | Australia |
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| Drug |
Orally administered tablets of placebo |
|
Area under the drug concentration-time curve (AUC)
| 8 days |
| To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants. | Apparent terminal half-life (t½) | 8 days |
| To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants. | Apparent total plasma clearance of drug (CL/F) | 8 days |
| To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants. | Apparent volume of distribution after oral administration (Vz/F) | 8 days |
| To evaluate the pharmacodynamics (PD) of HSK56630. | Change from baseline of VAV1 protein levels | 8 days |