drugset / Trial / NCT05391360

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

NCT05391360

Phase 1 Completed 128 enrolled Sunshine Lake Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

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

Timeline

Start
2021-10-11
Primary completion
2023-01-17
Completion
2023-01-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Entecavir Small molecule 0.5 mg
Subject Freethiadine Unknown 5 mg
Subject Freethiadine Unknown 10 mg
Subject Freethiadine Unknown 100 mg
Subject Freethiadine Unknown 150 mg
Subject Freethiadine Unknown 200 mg
Subject Freethiadine Unknown 300 mg
Subject Freethiadine Unknown 400 mg
Subject Freethiadine Unknown 600 mg