NCT05391360

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2022-05-25
• Last updated: 2023-04-12

Locations

2 sites across 1 country: China