The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

Study Overview
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Brief Summary
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The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Detailed Description
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A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Official Title
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A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

Conditions
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Chronic Hepatitis c

Intervention / Treatment
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* Drug: Kangdaprevir Sodium Tablet
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and sign the ICF voluntarily prior to initiate the study; Able to complete the study according to the protocol; Between 18 and 45 years of age（18 and 45 are inclusive）; Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）; Physical examination and vital signs without clinically significant abnormalities. Exclusion Criteria: Smokers, who smoke more than 5 cigarettes/day within 3 months before the study; Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine); Donated blood or massive blood loss within 3 months before screening (>450 mL）; Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers; Have take any drug that changes liver enzyme activity within 1 month before taking the study drug Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening; Have participated in any clinical trial or taken any study drug within 3 months before dosing; Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis. Have taken any alcoholic products within 24 hours prior to taking the study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg single dose<br>It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 100 mg single dose<br>Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 200 mg single dose<br>Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 400 mg single dose<br>Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 600 mg single dose<br>Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 800 mg single dose<br>Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 100 mg multiple dose<br>Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 200 mg multiple dose<br>Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|
| Experimental: 400 mg multiple dose<br>Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. | Drug: Kangdaprevir Sodium Tablet<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na;Drug: placebo<br>* Tablet，administered orally once daily<br>* Other names: HEC84048Na matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To assess the tolerability after a single and multiple dose of HEC84048 | Baseline to day 13 | 
| Cmax | Maximum observed plasma concentration of HEC84048 | predose to 72 hour after dosing | 
| Tmax | Time of the maximum observed plasma concentration of HEC84048 | predose to 72 hour after dosing | 
| AUC | Area under the plasma concentration-time curve (AUC) | predose to 72 hour after dosing | 
| T1/2 | Terminal elimination half-life | predose to 72 hour after dosing | 
| Vz/F | Apparent volume of distribution | predose to 72 hour after dosing | 
| CL/F | Oral clearance | predose to 72 hour after dosing | 
| MRT | Mean Residence Time | predose to 72 hour after dosing |