A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

Study Overview
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Brief Summary
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A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers

Detailed Description
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It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.

Official Title
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A Phase Ia Single-center,Randomized,Double-blind,Placebo-controled Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: Hepenofovir Fumarate Tablets Single Dose
* Drug: Placebo
* Drug: Hepenofovir Fumarate Tablets Dose4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the nature of the study, comply with the protocol, and provide informed consent. Subjects willing to adhere to protocol requirements and to finish the study. Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration. Subjects aged between 18 and 55 years (both inclusive). Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range. Exclusion Criteria: History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug). Hypersensitivity to different kinds of drugs and food. Presence of significant alcoholism or drug abuse. Volunteer who have donated blood or lose blood(>450mL)within past 90 days prior to the first dose of the study drug. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study. Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study. Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study. Any treatment which could bring about induction or inhibition of CYP3A4. Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug. Difficulty in swallowing or other gastrointestinal disease or disorder. Presence of an abnormal electrocardiogram (ECG), which was clinically significant. Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study. Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant. Subjects who, in the opinion of the Investigator, should not participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug SAD Cohorts<br>Hepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration. | Drug: Hepenofovir Fumarate Tablets Single Dose<br>* Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).<br>|
| Placebo Comparator: Placebo SAD Cohorts<br>Matching placebo, orally, once daily in one single administration. | Drug: Placebo<br>* Placebo to match Hepenofovir Fumarate Tablets<br>|
| Experimental: Drug MAD Group<br>Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days. | Drug: Hepenofovir Fumarate Tablets Single Dose<br>* Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).<br>|
| Placebo Comparator: Placebo MAD Group<br>Matching placebo, orally, once daily for 7 days. | Drug: Placebo<br>* Placebo to match Hepenofovir Fumarate Tablets<br>|
| Experimental: Food-influnced Group<br>Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition. | Drug: Hepenofovir Fumarate Tablets Dose4<br>* Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | Up to 6 Days in SAD Cohorts | 
| Safety measured by adverse events |  | Up to 12 Days in MAD Group | 
| Safety measured by adverse events |  | Up to 13 Days in Food-influence Group |