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.
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 69
- Primary Endpoint
- Safety measured by adverse events
Study Overview
Brief Summary
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 CYP3A
- •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.
Arms & Interventions
Drug SAD Cohorts
Hepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration.
Intervention: Hepenofovir Fumarate Tablets Single Dose (Drug)
Placebo SAD Cohorts
Matching placebo, orally, once daily in one single administration.
Intervention: Placebo (Drug)
Drug MAD Group
Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days.
Intervention: Hepenofovir Fumarate Tablets Single Dose (Drug)
Placebo MAD Group
Matching placebo, orally, once daily for 7 days.
Intervention: Placebo (Drug)
Food-influnced Group
Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition.
Intervention: Hepenofovir Fumarate Tablets Dose4 (Drug)
Outcomes
Primary Outcomes
Safety measured by adverse events
Time Frame: Up to 13 Days in Food-influence Group
Secondary Outcomes
No secondary outcomes reported