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Completed

NCT Number: NCT05492630

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects

The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects

Completed

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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 First Hospital of Jilin University

Changchun, Jilin, 130000, 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 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
  • subjects and must be 18 to 45 years of age inclusive.
  • Body weight ≥ 45 kg(for female) or ≥ 50 kg(for male) and body mass index(BMI)between 18 and 28 kg / m^2, inclusive, at screening.
  • There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening.
  • Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion criteria

  • Use of >5 cigarettes per day during the past 3 months.
  • Known history of allergy to study drugs,or allergies constitution ( multiple drug and food allergies).
  • History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 14 units/week).
  • Positive results from urine drug screen test.
  • Donation or loss of blood over 450 mL within 3 months prior to screening.
  • Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening.
  • Use of any prescription or non-prescription medications within 14 days prior to initial dosing
  • Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
  • Subjects who participated in another clinical trial within 3 months prior to initial dosing.
  • Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
  • Subjects deemed unsuitable by the investigator for any other reason.

Treatment and study plan

HEC73077 tablets

Drug

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

HEC73077 placebo tablets

Drug

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

Primary outcomes

  1. Adverse Events

    Time frame: Up to 19 days

    Incidence of adverse events

  2. Cmax

    Time frame: Day 1-17

    Maximum plasma concentration of study drugs

  3. AUC0-∞

    Time frame: Day 1-17

    area under the concentration versus time curve (AUC) from time zero to infinity

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 Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Randomized, Open-label, Food Effect Study of HEC73077 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Apr 12, 2023

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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