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

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.

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

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.

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.