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

Hepatitis B, Chronic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391360
• Other study ID #: HEC160208-HBV-101
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2021
• Est. completion date: January 17, 2023

Study information

• Verified date: May 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Freethiadine 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)
• Freethiadine tablets (part II)
once or twice daily for consecutive 28 days
• Freethiadine 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)
• entecavir tablets
once daily for consecutive 28 days

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	Southern Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of adverse events	From Days 1-35
Primary	AUC	Maximum plasma concentration of study drugs	Day 1-12
Primary	HBV DNA	Change from baseline in HBV DNA	Day 1-35
Secondary	HBsAg	Change from baseline in HBsAg	Day 1-35