A Phase I Pharmacokinetics Study for KT07 Capsule

Exclusion Criteria

• •1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
• •2. Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• •3. Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
• •4. Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
• •5. Positive SARS-CoV-2 testing by standard RT-PCR assay.
• •6. Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• •7. Positive urine test for ethanol/drug/cotinine at Screening or Day -1.
• •8. History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake \> 21 units/week or are unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until completion of the study. Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
• •9. History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator or are unwilling to abstain from illicit drug use consumption during the entire study. Positive drug test, including marijuana.
• •10. Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive consumption is defined as \>6 servings per day (1 serving contains approximately 120 mg caffeine).
• •11. Donation of blood (\> 500 mL) or blood products within 2 months prior to Day -1.
• •12. Use of over-the-counter (OTC) vitamins and medications, prescription medications, an investigational drug or herbal remedies from 14 days prior to the first dose.
• •13. Subject has a history of hypersensitivity to the investigational product (IP) or any of the ingredient or excipient of IP.
• •14. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to admission.
• •15. Subject has consumed grapefruit or grapefruit juice within the 14 days prior to admission.
• •16. Pregnant or breast-feeding female subjects
• •17. Previous history of difficulty swallowing capsules.
• •18. History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks of Torsade de Pointes or sudden premature death.
• •19. Subject with any of the following ECG results at Screening or Admission will be excluded:
• •1. PR interval \>220 msec or \<110 msec
• •2. RR interval \> 1333 msec
• •3. QRS interval \>120 msec
• •4. QTcF \>470 msec
• •5. ST segment elevation or depression considered clinically significant by the PI or designee
• •6. T-wave abnormalities considered to be clinically significant by the PI or designee
• •20. An average systolic blood pressure ≥140 mmHg or ≤ 90 mmHg; an average diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg.
• •21. Participants with history of hyperthyroidism and increased intraocular pressure.
• •22. Glomerular filtration rate (GFR) ≤70 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.at Screening
• •23. Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT), or alkaline phosphatase (ALP) \>1.2 × upper limit of the reference range (ULRR) at Screening or Admission
• •24. History of significant multiple and/or severe allergies (including latex allergy); anaphylactic reaction; or significant prescription drug, non-prescription drug, or food intolerance.
• •25. Any vaccination within 7 days of Screening or any vaccination with an mRNA or adenovirus platform vaccine within 30 days of Screening
• •26. Hemoglobin (HbA1C) \> 6.5
• •27. Any other factors that the Investigator considers not suitable for participating in this trial.
• •28. Subject is unable to understand the protocol requirements, instructions and study related restrictions, as well as the nature, scope, and possible consequences of the clinical study.
• •29. Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions, such as uncooperative attitude, inability to return for follow-up visits, and improbability of completing the clinical study.