The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

NCT03903081 | Completed Phase 1

• 1 other identifier: HEC110114-P-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Percentage of Participants with Adverse Events

  From Days 1-12

Secondary Outcomes (7)

• Cmax

  At pre-defined intervals from Days 1-12

• Tmax

  At pre-defined intervals from Days 1-12

• AUClast

  At pre-defined intervals from Days 1-12

• AUC0-∞

  At pre-defined intervals from Days 1-12

• T1/2

  At pre-defined intervals from Days 1-12

Study Arms (10)

100 mg single dose

EXPERIMENTAL

It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

300 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

600 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

800 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

1000 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

1200 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

1600 mg single dose

EXPERIMENTAL

Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

600 mg multiple doses

EXPERIMENTAL

Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

800 mg multiple doses

EXPERIMENTAL

Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

1000 mg multiple doses

EXPERIMENTAL

Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

Interventions

HEC110114 tablet DRUG

administered orally once daily

100 mg single dose; 1000 mg multiple doses; 1000 mg single dose; 1200 mg single dose; 1600 mg single dose; 300 mg single dose; 600 mg multiple doses; 600 mg single dose; 800 mg multiple doses; 800 mg single dose

Placebo Oral Tablet DRUG

Placebo will be administered orally at a dose and frequency matched to HEC110114

100 mg single dose; 1000 mg multiple doses; 1000 mg single dose; 1200 mg single dose; 1600 mg single dose; 300 mg single dose; 600 mg multiple doses; 600 mg single dose; 800 mg multiple doses; 800 mg single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
• Be able to complete the study according to the trail protocol
• Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures
• Male subjects and must be 18 to 45 years of age inclusive
• Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
• Physical examination and vital signs without clinically significant abnormalities.

You may not qualify if:

• Use of \>5 cigarettes per day during the past 3 months
• Allergies constitution ( multiple drug and food allergies)
• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
• Donation or loss of blood over 450 mL within 3 months prior to screening
• lead ECG with clinically significant
• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
• Subjects deemed unsuitable by the investigator for any other reason.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological 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: April 3, 2019
• First Posted: April 4, 2019
• Study Start: March 6, 2019
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: March 18, 2020

Record last verified: 2019-04

Locations

CN (1)