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The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

NCT ID: NCT03673696

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2019-07-05

Brief Summary

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The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

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Detailed Description

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A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.

Conditions

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Chronic Hepatitis c

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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50 mg single dose

It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

100 mg single dose

Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

200 mg single dose

Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

400 mg single dose

Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

600 mg single dose

Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

800 mg single dose

Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

100 mg multiple doses

Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

200 mg multiple doses

Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

400 mg multiple doses

Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.

Group Type EXPERIMENTAL

HEC74647PA Capsule

Intervention Type DRUG

Capsule administered orally once daily

placebo

Intervention Type DRUG

Matching Placebo Capsule

Interventions

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HEC74647PA Capsule

Capsule administered orally once daily

Intervention Type DRUG

placebo

Matching Placebo Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to comprehend and sign the ICF voluntarily prior to initiate the study;
* Able to complete the study according to the protocol;
* Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
* Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
* Physical examination and vital signs without clinically significant abnormalities.

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 acne, acute gastritis or stomach and duodenal ulcers;
* Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
* Have participated in any clinical trial or taken any study drug within 3 months before dosing;
* Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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HEC74647-P-01

Identifier Type: -

Identifier Source: org_study_id

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