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Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV Infection

NCT03588923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection.

Conditions

  • HCV Infection

Interventions

DRUG

SH229

tablet, oral, 400 mg once daily for 3 days

DRUG

Placebos

tablet, oral, once daily for 3 days

DRUG

SH229

tablet, oral, 600 mg once daily for 3 days

DRUG

Placebos

tablet, oral, once daily for 3 days

DRUG

SH229

tablet, oral, 800 mg once daily for 3 days

DRUG

Placebos

tablet, oral, once daily for 3 days

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · Phase I Clinical Trial Unit, The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-07
Primary Completion
2018-08-10
Completion
2018-08-10

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 NCT03588923 on ClinicalTrials.gov