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 —