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

Nanjing Sanhome Pharmaceutical, Co., Ltd.1 site in 1 country30 target enrollmentJuly 7, 2018

ConditionsHCV Infection

InterventionsSH229 Placebos

Overview

Phase: Phase 1
Intervention: SH229
Conditions: HCV Infection
Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 7, 2018

End Date

August 10, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose;
•18-65 years of age;
•Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
•No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Boceprevir, Telaprevir, Simeprevir, Sofosbuvir, Daclatasvir, Asunaprevir;
•No antiviral treatment such as immune modulators, thymosin or other immune stimulating factors, interferon, or Chinese herbs in the past 6 months;
•HCV RNA ≥10\*5 IU/mL at screening (Roche COBAS Taqman);
•Chronic genotype 1-6 HCV Infection;
•Serum ALT ≤10 times ULN;
•FibroScan score ≤17.5kPa within 6 months before screening or at screening, or absence of cirrhosis within 12 months before screening;
•Subjects are capable of understanding and complying with the protocol and have signed the informed consent form.

Exclusion Criteria

•Smoke more than 5 cigarettes per day within three months prior to screening;
•Subjects allergic to the study drug (including its excipients) or subjects who are prone to allergies;
•History of drug and/or alcohol abuse (alcohol consumption exceeding 14 units per week: 1 unit = 285 mL of beer, or 25 mL of hard liquor, or 100 mL of wine);
•Blood donation or massive blood loss (\> 450 mL) within three months prior to screening;
•History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc.;
•Subjects with dysphagia or with any gastrointestinal disorders (or postoperative conditions) that may affect the study drug absorption;
•Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
•Use of any drugs that alter liver enzyme activity within 28 days prior to screening;
•Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening;
•Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous activities or other factors that may affect the disposition of the study drug within 2 weeks prior to screening;