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OpenTrials
Completed

NCT Number: NCT04546984

Multiple Dose Safety, Tolerability, PK,PD and Food Effect Study of HEC96719 in Healthy Adult Subjects

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects

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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

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.
  • Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
  • Positive results from urine drug screen test.
  • Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
  • Subjects who plan to receive or have had organ transplants.
  • Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Treatment and study plan

HEC96719

Drug

Part 2:Mulltiple doses up to 10 days

Primary outcomes

  1. Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events

    Time frame: up to 17 days

    To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD

Secondary outcomes

  1. Cmax

    Time frame: up to 96 hours

    Maximum Plasma Concentration(Cmax)of HEC96719

  2. AUC

    Time frame: up to 96 hours

    Area Under the Curve(AUC) of HEC96719

  3. Tmax

    Time frame: up to 96 hours

    Maximum Peak Time(Tmax) of HEC96719

  4. T1/2

    Time frame: up to 96 hours

    Maximum Peak Time(Tmax) of HEC96719

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics,and Randomized, Open-label,Crossover, Food Effect Study of HEC96719 in Healthy Chinese Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
May 7, 2021

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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