The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

Study Overview
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Brief Summary
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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 HEC110114 Tablets 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 Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: HEC110114 tablet
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions Be able to complete the study according to the trail protocol Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures Male subjects and must be 18 to 45 years of age inclusive Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive Physical examination and vital signs without clinically significant abnormalities. Exclusion Criteria: Use of >5 cigarettes per day during the past 3 months Allergies constitution ( multiple drug and food allergies) History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine) Donation or loss of blood over 450 mL within 3 months prior to screening 12-lead ECG with clinically significant Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis Subjects deemed unsuitable by the investigator for any other reason.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg single dose<br>It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 300 mg single dose<br>Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 600 mg single dose<br>Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 800 mg single dose<br>Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 1000 mg single dose<br>Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 1200 mg single dose<br>Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 1600 mg single dose<br>Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 600 mg multiple doses<br>Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 800 mg multiple doses<br>Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|
| Experimental: 1000 mg multiple doses<br>Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days | Drug: HEC110114 tablet<br>* administered orally once daily<br>Drug: Placebo Oral Tablet<br>* Placebo will be administered orally at a dose and frequency matched to HEC110114<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Percentage of Participants with Adverse Events | From Days 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum Observed Plasma Concentration | At pre-defined intervals from Days 1-12 | 
| Tmax | Time to Maximum Observed Plasma Concentration | At pre-defined intervals from Days 1-12 | 
| AUClast | Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration | At pre-defined intervals from Days 1-12 | 
| AUC0-∞ | Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity | At pre-defined intervals from Days 1-12 | 
| T1/2 | Apparent Half-Life | At pre-defined intervals from Days 1-12 | 
| CL/F | Clearance (CL/F) of HEC110114 | At pre-defined intervals from Days 1-12 | 
| Cmin | Trough Plasma Concentration of HEC110114 | At pre-defined intervals from Days 1-11 for MAD |