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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05391360

Collaborator

(none)

128

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Drug: Freethiadine tablets(part I) Drug: Freethiadine tablets (part II) Drug: Freethiadine placebo tablets Drug: entecavir tablets	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Jul 11, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
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) 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)
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 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)
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) once or twice daily for consecutive 28 days
Active Comparator: entecavir tablets part 2(Patients with chronic hepatitis B): 0.5 mg	Drug: entecavir tablets once daily for consecutive 28 days

Outcome Measures

Primary Outcome Measures

Adverse Events [From Days 1-35]
Incidence of adverse events
AUC [Day 1-12]
Maximum plasma concentration of study drugs
HBV DNA [Day 1-35]
Change from baseline in HBV DNA

Secondary Outcome Measures

HBsAg [Day 1-35]
Change from baseline in HBsAg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Hospital of Southern Medical University	Guangzhou	Guangdong	China	510000
2	The First Hospital of Jilin University	Changchun	Jilin	China	130000

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

Principal Investigator: 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