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Completed

NCT Number: NCT05391360

Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

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

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southern Hospital of Southern Medical University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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 (part II)

Drug

once or twice daily for consecutive 28 days

Freethiadine placebo tablets

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)

entecavir tablets

Drug

once daily for consecutive 28 days

Primary outcomes

  1. Adverse Events

    Time frame: From Days 1-35

    Incidence of adverse events

  2. AUC

    Time frame: Day 1-12

    Maximum plasma concentration of study drugs

  3. HBV DNA

    Time frame: Day 1-35

    Change from baseline in HBV DNA

Secondary outcomes

  1. HBsAg

    Time frame: Day 1-35

    Change from baseline in HBsAg

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Study in Healthy Subjects and Chronic Hepatitis B Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Freethiadine

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 25, 2022
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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