NCT05391360

Brief Summary

The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2023

Completed
Last Updated

April 12, 2023

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

May 20, 2022

Last Update Submit

April 11, 2023

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (3)

  • Adverse Events

    Incidence of adverse events

    From Days 1-35

  • AUC

    Maximum plasma concentration of study drugs

    Day 1-12

  • HBV DNA

    Change from baseline in HBV DNA

    Day 1-35

Secondary Outcomes (1)

  • HBsAg

    Day 1-35

Study Arms (4)

Freethiadine tablets

EXPERIMENTAL

part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg

Drug: Freethiadine tablets(part I)

Freethiadine placebo tablets

PLACEBO COMPARATOR

part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg

Drug: Freethiadine placebo tablets

Freethiadine tablet

EXPERIMENTAL

part 2(Patients with chronic hepatitis B): There will be a total of 4 dose cohorts:100 mg、200 mg(BID or QD)、300 mg

Drug: Freethiadine tablets (part II)

entecavir tablets

ACTIVE COMPARATOR

part 2(Patients with chronic hepatitis B): 0.5 mg

Drug: entecavir tablets

Interventions

Freethiadine tablets(part I)DRUG

Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)

Freethiadine tablets
Freethiadine tablets (part II)DRUG

once or twice daily for consecutive 28 days

Freethiadine tablet
Freethiadine placebo tabletsDRUG

Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)

Freethiadine placebo tablets
entecavir tabletsDRUG

once daily for consecutive 28 days

entecavir tablets

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health volunteer:
  • Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  • subjects and must be 18 to 45 years of age inclusive.
  • Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
  • Physical examination and vital signs without clinically significant abnormalities.
  • Patients with chronic hepatitis B:
  • Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  • subjects and must be 18 to 65 years of age inclusive.
  • Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
  • No cirrhosis.

You may not qualify if:

  • Health volunteer:
  • Use of \>5 cigarettes per day during the past 3 months.
  • History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
  • Donation or loss of blood over 450 mL within 3 months prior to screening.
  • Patients with chronic hepatitis B:
  • AFP\>50 ng/mL.
  • INR\>1.5.
  • Positive for Viral hepatitis C, HIV and syphilis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southern Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JinLin Hou, Doctor

    Southern Hospital of Southern Medical University

    PRINCIPAL INVESTIGATOR

  • JunQI Niu, Doctor

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

  • Yanhua Ding, Doctor

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

October 11, 2021

Primary Completion

January 17, 2023

Study Completion

January 17, 2023

Last Updated

April 12, 2023

Record last verified: 2022-05

Locations

CN(2)