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

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: Hepenofovir Fumarate Tablets Single Dose; Drug: Placebo; Drug: Hepenofovir Fumarate Tablets Dose4

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 Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug SAD Cohorts; 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; 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).
Placebo Comparator: Placebo SAD Cohorts; Matching placebo, orally, once daily in one single administration.	Drug: Placebo; Placebo to match Hepenofovir Fumarate Tablets
Experimental: Drug MAD Group; Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days.	Drug: Hepenofovir Fumarate Tablets Single Dose; 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).
Placebo Comparator: Placebo MAD Group; Matching placebo, orally, once daily for 7 days.	Drug: Placebo; Placebo to match Hepenofovir Fumarate Tablets
Experimental: 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.	Drug: Hepenofovir Fumarate Tablets Dose4; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: XAXT-2019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No