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

NCT05391360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-04-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JinLin Hou, Doctor · Southern Hospital of Southern Medical University

  • JunQI Niu, Doctor · The First Hospital of Jilin University

  • Yanhua Ding, Doctor · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391360 on ClinicalTrials.gov