| Eligibility |
Inclusion Criteria:
1. Subjects fully understand the purpose, nature, methods and possible adverse reactions
of the trial, voluntarily participate in the trial, and sign an informed consent form
before any trial procedure, and promise to participate in all procedure of the trial.
2. Healthy Chinese male subjects aged 18 to 55 (inclusive) at the time of signing
informed consent form.
3. Body mass index (BMI) ranges from 19.0 to 26.0 kg/m2 (inclusive); body weight = 50.0
kg.
4. Subjects can communicate well with the investigators and understand and abide by the
requirements of this trial.
Exclusion Criteria:
1. Subjects with past and present diseases with clinical abnormality in the opinion of
the investigator, including but not limited to disease concerning nervous system,
cardiovascular system, blood and lymphatic system, immune system, kidney, liver,
gastrointestinal tract, respiratory system, metabolic system and skeletal system;
2. Subjects with allergic history (including drug and food allergies, etc.).
3. Subjects with history of dysphagia or any gastrointestinal disease that affects drug
absorption judged by the investigator.
4. Subjects who have received surgery within 3 months before screening, or plan to have
surgery during the trial period, or those who had surgery that will affects drug
absorption (e.g. gastrectomy).
5. Subjects who cannot tolerate venipuncture, or have a history of needlesickness and
fainting at the sight of blood.
6. Subject with lactose intolerability (who having had milk diarrhea).
7. Subjects who have drug abuse history within 6 months before screening, or have a
positive urine drug screening (screening or baseline period) result.
8. Subjects who have used narcotics within 3 months before screening.
9. Subjects who consumed an average of more than 14 units of alcohol per week (1 unit of
alcohol = 360 mL beer, 150 mL wine, or 45 mL liquor) within 3 months before screening,
or who had a positive result of alcohol breath test (screening or baseline period), or
could not give up alcohol during the trial.
10. Subjects who consumed an average of more than 5 cigarettes per day within 3 months
before screening, or who could not stop using any tobacco products during the trial.
11. Subjects who consumed an average of excessive amounts of tea, coffee and / or
caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months
before screening.
12. Subjects who have participated in clinical trials of other study drugs/devices within
3 months before the first dose of the investigational drug, or have participated in 3
or more clinical trials of drugs/devices in the past year; if other study drugs have a
longer half-life, the time interval will be longer and is required to be 5 half-lives
of the drug.
13. Subjects who donated blood including blood component or have massive blood loss (2,200
mL), or received blood transfusion or used blood products within 3 months before
screening.
14. Subjects who received vaccination within 4 weeks before screening.
15. Subjects who have taken any drugs [such as: barbiturates, carbamazepine, phenytoin,
glucocorticoids, omeprazole; SSRI antidepressants, cimetidine, macrolides,
nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, antivirals
(such as saquinavir), calcium antagonists (such as diltiazem, verapamil), rifamycins
(such as rifampin)] that inhibit or induce the liver to metabolize drug within 28 days
before the first dose of the investigational drug. If the past drug used has a longer
half-life, the time interval will be longer and is required to be 5 half-lives of the
drug, eg, Phenobarbital requires a 5-week washout period.
16. Subjects who have taken prescription drugs, over-the-counter drugs, dietary
supplements or Chinese herbal medicine within 14 days before the first dose of the
investigational drug. If the past drug used has a longer half-life, the time interval
will be longer and is required to be 5 half-lives of the drug.
17. Any test result of hepatitis B surface antigen, hepatitis C virus antibody, human
immunodeficiency virus (HIV) antibody, or treponema pallidum antibody is positive.
18. At screening, vital signs (blood pressure, pulse and body temperature) examination,
comprehensive physical examination and laboratory tests (hematology, blood
biochemistry, urinalysis) indicate abnormal results with clinical significance
according to the investigator. The reference normal range of vital signs (including
the cut-off value) is as follows: Sitting systolic blood pressure is 90 to 139 mmHg,
diastolic blood pressure is 60 to 89 mmHg, pulse is 50 to 100 bmp, body temperature
(frontal temperature) is 36.0 to 37.0°C. The specific situation is comprehensively
determined by the investigator.
19. At screening after a quiet rest for at least 10 min, the corrected QT interval
(corrected by Fridericia's formula, QTcF = QT/RR1/3) > 450 msec or QRS complex > 120
msec was obtained by 12-lead ECG in supine position. If QTcF is more than 450 msec or
QRS is more than 120 msec, 12-lead ECG measurement should be repeated twice, and the
average value of QTcF or QRS measured three times is judged by the investigator as
abnormality with clinical significance.
20. Subjects who are allergic to IMP4297, Itraconazole, Rifampicin, or to any ingredients
of these preparations.
21. Vigorous exercise cannot be avoided within 48 hours before the first dose of the
investigational drug and during the trial.
22. Subjects who consumed any food or beverages containing alcohol, caffeine, chocolate,
or rich in xanthine within 48 hours before the first dose of the investigational drug;
or those who cannot abstain from these products during the trial.
23. Subjects who cannot abstain from grapefruit or grapefruit-related citrus (eg, pomelo)
or juice within 7 days before the first dose of investigational drug and during the
trial;
24. Subjects or its partners who have birth plan, or are unwilling to adopt effective
contraception methods (Annex 2), or have sperm donation plan throughout the trial and
within 180 days after the last dose of the investigational drug.
25. Subjects who are unwilling or unable to follow the lifestyle guidelines described in
the study protocol (such as dietary restrictions and activity requirements).
26. Subjects who have other acute or chronic medical or psychiatric diseases, which may
increase the risks of participating in this trial, or may interfere with the
interpretation of the trial results, will be judged unsuitable to participate in this
trial by the investigator.
27. Subjects judged by the investigator to be unsuitable for participation in the trial.
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