NCT03588923

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

A Randomized, Double-blind, Placebo-controlled Phase I Study to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 30 evaluable patients will be enrolled in this study. The planned dose levels are 400, 600, and 800 mg.

Conditions

• HCV Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-07
• Primary completion: 2018-08-10
• Completion: 2018-08-10
• First posted: 2018-07-17
• Last updated: 2018-08-28

Locations

1 site across 1 country: China