A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664

Conditions
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Healthy

Intervention / Treatment
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* Drug: HNC664 capsules Single dose
* Drug: HNC664 placebos Single dose
* Drug: HNC664 capsules FED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer, age 18-65 years BMI between 18-32 kg/m2,and body weight not less than 50.0kg. Exclusion Criteria: Any condition that might interfere with the procedures or tests in this study Drug or alcohol abuse Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HNC664 capsules<br>HNC664 capsules,single ascending doses Single dose | Drug: HNC664 capsules Single dose<br>* HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg<br>* Other names: HNC664 capsules;|
| Placebo Comparator: HNC664 placebos<br>HNC664 placebos,single ascending doses Single dose | Drug: HNC664 placebos Single dose<br>* HNC664 placebos single ascending doses,PO,Single dose, matching placebo<br>* Other names: HNC664 placebos;|
| Experimental: HNC664 capsules FED<br>HNC664 capsules,food effect,Single dose | Drug: HNC664 capsules FED<br>* HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）<br>* Other names: HNC664 capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |