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Completed

NCT Number: NCT03903081

The Tolerability and Pharmacokinetics Study 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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEC110114 Tablet

Drug

administered orally once daily

Placebo oral tablet

Drug

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

Primary outcomes

  1. Adverse Events

    Time frame: From Days 1-12

    Percentage of Participants with Adverse Events

Secondary outcomes

  1. Cmax

    Time frame: At pre-defined intervals from Days 1-12

    Maximum Observed Plasma Concentration

  2. Tmax

    Time frame: At pre-defined intervals from Days 1-12

    Time to Maximum Observed Plasma Concentration

  3. AUClast

    Time frame: At pre-defined intervals from Days 1-12

    Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration

  4. AUC0-∞

    Time frame: At pre-defined intervals from Days 1-12

    Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity

  5. T1/2

    Time frame: At pre-defined intervals from Days 1-12

    Apparent Half-Life

  6. CL/F

    Time frame: At pre-defined intervals from Days 1-12

    Clearance (CL/F) of HEC110114

  7. Cmin

    Time frame: At pre-defined intervals from Days 1-11 for MAD

    Trough Plasma Concentration of HEC110114

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: HEC110114

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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