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

NCT03588923 | Completed Phase 1

• 1 other identifier: SHC005-I-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HCV Infection

Keywords

HCV; NS5B; SH229

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  up to Day 10

• Antiviral effects of SH229, as measured by HCV RNA levels

  up to Day 10

Secondary Outcomes (4)

• Time to peak plasma concentration(Tmax)

  up to Day 10

• Peak plasma concentration(Cmax)

  up to Day 10

• Half-life time(t1/2)

  up to Day 10

• Area under the plasma concentration versus time curve(AUC)

  up to Day 10

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

SH229 (400 mg) or matching placebo, once daily

Drug: SH229; Drug: Placebos

Cohort 2

ACTIVE COMPARATOR

SH229 (600 mg) or matching placebo, once daily

Drug: SH229; Drug: Placebos

Cohort 3

ACTIVE COMPARATOR

SH229 (800 mg) or matching placebo, once daily

Drug: SH229; Drug: Placebos

Interventions

SH229 DRUG

tablet, oral, 400 mg once daily for 3 days

Cohort 1

Placebos DRUG

tablet, oral, once daily for 3 days

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose;
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Nanjing Sanhome Pharmaceutical, Co., Ltd.: lead

Study Sites (1)

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

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yanhua Ding, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 17, 2018
• Study Start: July 7, 2018
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)