NCT04201275

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

Detailed description

All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	HEC74647PA capsule	Capsule administered orally once daily
DRUG	placebo	HEC74647PA capsule matching placebo administered orally once daily

Timeline

• Start date: 2019-12-18
• Primary completion: 2020-01-17
• Completion: 2020-01-21
• First posted: 2019-12-17
• Last updated: 2020-03-19

Locations

1 site across 1 country: China