Clinical trial NCT04277897: A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Hepatitis b
Lead sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 6 Days in SAD Cohorts
measure: Safety measured by adverse events
timeFrame: Up to 12 Days in MAD Group
measure: Safety measured by adverse events
timeFrame: Up to 13 Days in Food-influence Group
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: