NCT05391360 - Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study | Biotech Hunter

Enrollment

128

Participants

Timeline

Start Date

October 11, 2021

Primary Completion Date

January 17, 2023

Study Completion Date

January 17, 2023

Conditions

Hepatitis B, Chronic

Interventions

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)

DRUG

Freethiadine tablets (part II)

once or twice daily for consecutive 28 days

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)

DRUG

entecavir tablets

once daily for consecutive 28 days

Trial Locations (2)

130000

The First Hospital of Jilin University, Changchun

510000

Southern Hospital of Southern Medical University, Guangzhou

All Listed Sponsors

lead

Sunshine Lake Pharma Co., Ltd.

INDUSTRY