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

NCT ID: NCT03588923

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-07
• Study Completion Date: 2018-08-10

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.

Conditions

HCV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

SH229 (400 mg) or matching placebo, once daily

Group Type: ACTIVE_COMPARATOR

SH229

Intervention Type: DRUG

tablet, oral, 400 mg once daily for 3 days

Placebos

Intervention Type: DRUG

tablet, oral, once daily for 3 days

Cohort 2

SH229 (600 mg) or matching placebo, once daily

Group Type: ACTIVE_COMPARATOR

SH229

Intervention Type: DRUG

tablet, oral, 600 mg once daily for 3 days

Placebos

Intervention Type: DRUG

tablet, oral, once daily for 3 days

Cohort 3

SH229 (800 mg) or matching placebo, once daily

Group Type: ACTIVE_COMPARATOR

SH229

Intervention Type: DRUG

tablet, oral, 800 mg once daily for 3 days

Placebos

Intervention Type: DRUG

tablet, oral, once daily for 3 days

Interventions

SH229

tablet, oral, 400 mg once daily for 3 days

Intervention Type: DRUG

Placebos

tablet, oral, once daily for 3 days

Intervention Type: DRUG

SH229

tablet, oral, 600 mg once daily for 3 days

Intervention Type: DRUG

Placebos

tablet, oral, once daily for 3 days

Intervention Type: DRUG

SH229

tablet, oral, 800 mg once daily for 3 days

Intervention Type: DRUG

Placebos

tablet, oral, once daily for 3 days

Intervention Type: DRUG

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;
• Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
• Subjects with major changes in diet or exercise habits recently;
• Participation in other clinical trials within three months prior to enrollment;
• Electrocardiogram abnormalities with clinical significance;
• Laboratory tests with clinical significance or other clinical findings that indicate clinically significant diseases not associated with HCV infection (including but not limited to gastrointestinal, renal, hepatic, neurologic, hematological, endocrine, pulmonary, psychiatric, cardiovascular diseases);
• Pregnant or lactating women;
• Creatinine clearance ≤ 60 mL/min;
• Evidence of co-infection with HBV, HIV, or syphilis;
• Child-Pugh Grade B or C;
• Clinically significant hepatic decompensation including but not limited to, hepatic encephalopathy, hepatocellular carcinoma, variceal bleeding, ascites, etc.;
• Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours prior to dosing;
• Use of products containing alcohol within 24 hours prior to dosing;
• Subjects with urine drug screening test positive, or with history of drug abuse in the past 5 years;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sanhome Pharmaceutical, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, MD

Role: PRINCIPAL_INVESTIGATOR

Phase I Clinical Trial Unit, The First Hospital of Jilin University

Locations

Phase I Clinical Trial Unit, The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

SHC005-I-03

Identifier Type: -

Identifier Source: org_study_id