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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 12-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 100 mg single dose; 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; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 300 mg single dose; Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 600 mg single dose; Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 800 mg single dose; 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; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 1000 mg single dose; Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 1200 mg single dose; Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 1600 mg single dose; Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 600 mg multiple doses; Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 800 mg multiple doses; Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114
EXPERIMENTAL: 1000 mg multiple doses; Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days	Drug: HEC110114 tablet; administered orally once daily; Drug: Placebo Oral Tablet; Placebo will be administered orally at a dose and frequency matched to HEC110114

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Percentage of Participants with Adverse Events	From Days 1-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-12
Tmax	Time to Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-12
AUClast	Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration	At pre-defined intervals from Days 1-12
AUC0-∞	Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity	At pre-defined intervals from Days 1-12
T1/2	Apparent Half-Life	At pre-defined intervals from Days 1-12
CL/F	Clearance (CL/F) of HEC110114	At pre-defined intervals from Days 1-12
Cmin	Trough Plasma Concentration of HEC110114	At pre-defined intervals from Days 1-11 for MAD

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2019
• Primary Completion (ACTUAL): October 29, 2019
• Study Completion (ACTUAL): October 29, 2019

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (ACTUAL): April 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: HEC110114-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No