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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis B, Chronic

Treatments: Drug: Freethiadine placebo tablets; Drug: Freethiadine tablets (part II); Drug: Freethiadine tablets(part I); Drug: entecavir tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05391360

HEC160208-HBV-101

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

Freethiadine tablets

Experimental group

Description:

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

Treatment:

Drug: Freethiadine tablets(part I)

Freethiadine placebo tablets

Placebo Comparator group

Description:

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

Treatment:

Drug: Freethiadine placebo tablets

Freethiadine tablet

Experimental group

Description:

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

Treatment:

Drug: Freethiadine tablets (part II)

entecavir tablets

Active Comparator group

Description:

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

Treatment:

Drug: entecavir tablets