NCT04201275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

December 13, 2019

Last Update Submit

March 17, 2020

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (7)

  • Adverse Events,laboratory abnormalities and other abnormalities

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

    8 days

  • Antiviral Activity

    Change from baseline in HCV RNA following dose administration of HEC74647

    8 days

  • 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

    8 days

  • Cmax

    Maximum observed plasma concentration of HEC74647

    8 days

  • Tmax

    Time of the maximum observed plasma concentration

    8 days

  • AUC

    Area under the plasma concentration-time curve (AUC)

    8 days

  • t1/2

    Terminal elimination half-life

    8 days

Study Arms (4)

Cohort 1

EXPERIMENTAL

up to HEC74647PA capsule 50 mg once daily for 3 days

Drug: HEC74647PA capsule

Cohort 2

EXPERIMENTAL

up to HEC74647PA capsule 100 mg once daily for 3 days

Drug: HEC74647PA capsule

Cohort 3

EXPERIMENTAL

up to HEC74647PA capsule 200 mg once daily for 3 days

Drug: HEC74647PA capsule

Cohort 4

PLACEBO COMPARATOR

up to placebo once daily for 3 days

Drug: placebo

Interventions

HEC74647PA capsuleDRUG

Capsule administered orally once daily

Cohort 1Cohort 2Cohort 3
placeboDRUG

HEC74647PA capsule matching placebo administered orally once daily

Cohort 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yanhua Ding, Doctor

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 17, 2019

Study Start

December 18, 2019

Primary Completion

January 17, 2020

Study Completion

January 21, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)