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CompletedNCT05391360Updated Apr 12, 2023

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

A Phase 1 interventional study of Freethiadine tablets(part I) and Freethiadine tablets (part II) in Hepatitis B, Chronic, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2021, registered May 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hepatitis B, Chronic
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 128 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Health volunteer:

  1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  2. subjects and must be 18 to 45 years of age inclusive.
  3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
  4. Physical examination and vital signs without clinically significant abnormalities.

Patients with chronic hepatitis B:

  1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  2. subjects and must be 18 to 65 years of age inclusive.
  3. Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
  4. No cirrhosis.

Exclusion criteria

Exclusion Criteria:

Health volunteer:

  1. Use of >5 cigarettes per day during the past 3 months.
  2. 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).
  3. Donation or loss of blood over 450 mL within 3 months prior to screening.

Patients with chronic hepatitis B:

  1. AFP>50 ng/mL.
  2. INR>1.5.
  3. Positive for Viral hepatitis C, HIV and syphilis.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Freethiadine tablets

    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)

  • Placebo comparator
    Freethiadine placebo tablets

    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

  • Experimental
    Freethiadine tablet

    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)

  • Active comparator
    entecavir tablets

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

    Drug: entecavir tablets

Interventions

  • DrugFreethiadine tablets(part I)

    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)

  • DrugFreethiadine tablets (part II)

    once or twice daily for consecutive 28 days

  • DrugFreethiadine placebo tablets

    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)

  • Drugentecavir tablets

    once daily for consecutive 28 days

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Incidence of adverse events

    Time frame: From Days 1-35

  2. AUC

    Maximum plasma concentration of study drugs

    Time frame: Day 1-12

  3. HBV DNA

    Change from baseline in HBV DNA

    Time frame: Day 1-35

Secondary outcomes

  1. HBsAg

    Change from baseline in HBsAg

    Time frame: Day 1-35

07

Study locations

2 sites
  • Southern Hospital of Southern Medical University
    Guangzhou, Guangdong 510000, China
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05391360
Lead sponsor
Sunshine Lake Pharma Co., Ltd.
Responsible party
Sponsor
First posted
May 25, 2022
Start date
Oct 11, 2021
Primary completion
Jan 17, 2023
Completion
Jan 17, 2023
Last update
Apr 12, 2023

Study contacts

JinLin Hou, Doctor
principal investigator · Southern Hospital of Southern Medical University
JunQI Niu, Doctor
principal investigator · The First Hospital of Jilin University
Yanhua Ding, Doctor
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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