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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HEC74647PA capsule

placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able to comprehend and sign the ICF voluntarily prior to initiate the study;
Able to complete the study according to the protocol;
Agree to use protocol defined precautions against pregnancy
Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
HCV treatment-naïve adult subjects with GT1-6 HCV infection
HCV RNA level ≥ 5 log10 IU/mL at screening
FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis

Exclusion Criteria:

Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
Donated blood or massive blood loss within 3 months before screening (>450 mL）;
Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;
Have participated in any clinical trial or taken any study drug within 3 months before dosing;
Positive test result of HBV,HIV or syphilis;
Solid organ transplanters

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

up to HEC74647PA capsule 50 mg once daily for 3 days

up to HEC74647PA capsule 100 mg once daily for 3 days

up to HEC74647PA capsule 200 mg once daily for 3 days

up to placebo once daily for 3 days

Outcomes

Primary Outcome Measures

Adverse Events,laboratory abnormalities and other abnormalities

Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647

Antiviral Activity

Change from baseline in HCV RNA following dose administration of HEC74647

Sequence changes in the NS5A coding region

Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter

Cmax

Maximum observed plasma concentration of HEC74647

Tmax

Time of the maximum observed plasma concentration

AUC

Area under the plasma concentration-time curve (AUC)

t1/2

Terminal elimination half-life

Secondary Outcome Measures

Full Information

NCT ID

NCT04201275

First Posted

December 13, 2019

Last Updated

March 17, 2020

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04201275

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

December 18, 2019 (Actual)

Primary Completion Date

January 17, 2020 (Actual)

Study Completion Date

January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

up to HEC74647PA capsule 50 mg once daily for 3 days

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

up to HEC74647PA capsule 100 mg once daily for 3 days

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

up to HEC74647PA capsule 200 mg once daily for 3 days

Arm Title

Cohort 4

Arm Type

Placebo Comparator

Arm Description

up to placebo once daily for 3 days

Intervention Type

Drug

Intervention Name(s)

HEC74647PA capsule

Intervention Description

Capsule administered orally once daily

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

HEC74647PA capsule matching placebo administered orally once daily

Primary Outcome Measure Information:

Title

Adverse Events,laboratory abnormalities and other abnormalities

Description

Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647

Time Frame

8 days

Title

Antiviral Activity

Description

Change from baseline in HCV RNA following dose administration of HEC74647

Time Frame

8 days

Title

Sequence changes in the NS5A coding region

Description

Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter

Time Frame

8 days

Title

Cmax

Description

Maximum observed plasma concentration of HEC74647

Time Frame

8 days

Title

Tmax

Description

Time of the maximum observed plasma concentration

Time Frame

8 days

Title

AUC

Description

Area under the plasma concentration-time curve (AUC)

Time Frame

8 days

Title

t1/2

Description

Terminal elimination half-life

Time Frame

8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to comprehend and sign the ICF voluntarily prior to initiate the study; Able to complete the study according to the protocol; Agree to use protocol defined precautions against pregnancy Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive; HCV treatment-naïve adult subjects with GT1-6 HCV infection HCV RNA level ≥ 5 log10 IU/mL at screening FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis Exclusion Criteria: Smokers, who smoke more than 5 cigarettes/day within 3 months before the study; Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine); Donated blood or massive blood loss within 3 months before screening (>450 mL）; Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers; Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening; Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole; Have participated in any clinical trial or taken any study drug within 3 months before dosing; Positive test result of HBV,HIV or syphilis; Solid organ transplanters

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanhua Ding, Doctor

Organizational Affiliation

The First Hospital of Jilin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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