A PhaseⅠFood-Effect Study of Hemay022 in Healthy Subjects

Tianjin Hemay Oncology Pharmaceutical Co., Ltd1 site in 1 country12 target enrollmentDecember 9, 2020

ConditionsFood-drug Interaction

InterventionsHemay022

DrugsHemay022

Overview

Phase: Phase 1
Intervention: Hemay022
Conditions: Food-drug Interaction
Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd
Enrollment: 12
Locations: 1
Primary Endpoint: Cmax
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.

Registry

clinicaltrials.gov

Start Date

December 9, 2020

End Date

May 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Tianjin Hemay Oncology Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18-40 years old, the ratio of male to female is 1:1, the age difference of the same batch of subjects is less than 10 years;
•Weight: male should not be less than 50kg, female should be no less than 45kg, body mass index (BMI) \[=weight (kg)/height 2 (m2)\] between 19-24 (including boundary values);
•90mmHg≤systolic blood pressure≤140mmHg, 60mmHg≤diastolic blood pressure≤90 mmHg, 55 beats/min≤pulse≤100 beats/min, 12 breaths/min≤respiration≤24 breaths/min, normal body temperature;
•Before the trial, the subjects have understood the nature, significance, possible benefits and possible inconveniences and potential dangers of the trial in detail, and volunteered to participate in the clinical trial, can communicate well with the investigator, comply with the requirements of the entire study, and Signed a written informed consent form.

Exclusion Criteria

•Participated in other drug clinical trials within 3 months;
•(Inquiry)Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones;
•(Inquiry)Those who have a history of severe vomiting, diarrhea or any other diseases or physiological conditions that can interfere with the study results within 7 days before the trial;
•(Inquiry)People with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as those who are allergic to two or more drugs, food or pollen), or those who are known to be allergic to tiniba drugs;
•(Inquiry) Those who lost blood or donated more than 400ml of blood within 3 months before this clinical trial, or plan to donate blood during the trial;
•Inquiry) Pregnant or lactating female, or subjects (including male subjects) have a childbirth plan or sperm donation plan within 3 months after the last dose, unwilling or unwilling Those who take effective contraceptive measures;
•General physical examination and laboratory examination (blood routine, stool routine, blood biochemistry, coagulation function, urine routine, blood human chorionic gonadotropin/urinary pregnancy (female), etc.) within 7 days before the test, 6 months before the test The result of internal chest radiograph is judged by clinicians as abnormal and clinically significant;
•Subjects whose left ventricular ejection fraction (LVEF) measured by MUGA scan or echocardiography is less than 50%;
•Patients with clinically significant ECG abnormalities in the 14 days before the test, including: QTc (corrected by bazett or fridericia) interval prolonged (≥450ms) on the screening ECG, QRS\>120ms;
•One or more test results of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or Treponema pallidum antibody are positive;