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Completed

NCT Number: NCT04194242

The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Shanghai xuhui district central hospital

Shanghai, Shanghai Municipality, China

About this study

This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
  • Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
  • When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
  • Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
  • No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion criteria

  • Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
  • Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
  • Intemperant or regular drinkers within 3 months prior to the study, i.e., those who consumed more than 21 units of alcohol per week (1 unit =360mL beer or 45mL spirit with 40% alcohol or 150mL wine), or those who were positive on the alcohol breath test.
  • Those who had a blood donation or blood loss of >400mL within one month before taking the study drug.
  • Those who have participated in clinical trials of other drugs within 3 months before randomization.
  • Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Treatment and study plan

HEC96719 tablets

Drug

0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1

Placebo Tablet

Drug

0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1

Primary outcomes

  1. Adverse events of the single ascending-dose

    Time frame: From the baseline to day7

    To assess the safe and tolerability of the single ascending-dose

Secondary outcomes

  1. Cmax

    Time frame: At pre-defined intervals from Days 1-2

    Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose

  2. AUC

    Time frame: At pre-defined intervals from Days 1-2

    Area Under the Curve(AUC) of HEC96719 in single ascending dose

  3. Tmax

    Time frame: At pre-defined intervals from Days 1-2

    Maximum Peak Time(Tmax) of HEC96719 in single ascending dose

  4. T1/2

    Time frame: At pre-defined intervals from Days 1-2

    Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose

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 Ascending Dose Study to Access the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Chinese Healthy Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Dec 28, 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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