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The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNC664 capsules | Experimental | HNC664 capsules,single ascending doses Single dose |
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| HNC664 placebos | Placebo Comparator | HNC664 placebos,single ascending doses Single dose |
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| HNC664 capsules FED | Experimental | HNC664 capsules,food effect,Single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HNC664 capsules Single dose | Drug | HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and concomitant medications | To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs. | Between screening and 7-9 days after the last dose |
| Number of subjects with vital sign measurements | To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs | Between screening and 7-9 days after the last dose |
| Number of subjects with clinical laboratory test results | To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results | Between screening and 7-9 days after the last dose |
| Number of subjects with 12-lead ECGs | To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs | Between screening and 7-9 days after the last dose |
| Number of subjects with physical examinations | To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations | Between screening and 7-9 days after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron | Baltimore | Maryland | 21201 | United States |
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| HNC664 placebos Single dose | Drug | HNC664 placebos single ascending doses,PO,Single dose, matching placebo |
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| HNC664 capsules FED | Drug | HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC） |
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