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

Phase 1

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Freethiadine tablets (part II); Drug: entecavir tablets; Drug: Freethiadine tablets(part I); Drug: Freethiadine placebo tablets

• Registration Number: NCT05391360
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-11
• Status Verified: 2022-05
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Primary Completion: 2023-01-17
• Study Completion: 2023-01-17
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freethiadine tablet	Freethiadine tablets (part II)	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
entecavir tablets	entecavir tablets	part 2(Patients with chronic hepatitis B): 0.5 mg
Freethiadine tablets	Freethiadine tablets(part I)	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
Freethiadine placebo tablets	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
HBsAg	Day 1-35	Change from baseline in HBsAg

Trial Locations

Locations (2)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Southern Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China