Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults

Exclusion Criteria

• •Subjects will be excluded from the study, if they meet ANY of the following criteria:
• •Subjects will be excluded from the study, if they meet ANY of the following criteria:
• •1. Subjects who have difficulties in venous blood collection or history of dizziness with blood or needles
• •2. Female subjects who have a positive pregnancy test or are breastfeeding
• •3. Subjects who have allergy/hypersensitivity history to any excipient of CBP-174 solution, or hypersensitivity to antihistamines, or severe allergies at the discretion of Investigator
• •4. Exposure to any other investigational medicinal product or any other clinical trial within 30 days or 5 times half-lives (whichever is longer) before dosing current study medication
• •5. Subjects who have a history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, etc.), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• •6. Subjects who have a history of significant eye diseases (such as keratitis, and scleritis, etc.) or clinical significant eye signs (conjunctiva hyperemia, etc.)
• •7. Subjects who have a history of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
• •8. Subjects who have a history of sleep disorders within 2 years before the screening visit or score highly on the PSQI or ISI questionaire; or have a history of epilepsy or other seizure disorder
• •\*Pittsburgh Sleep Quality Index (PSQI) ≥ 8 or Insomnia Severity Index (ISI) ≥ 8
• •9. Subjects who have the medical history of other significant diseases (including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological endocrinological, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases) or any other disease/ailment at the discretion of the Investigator
• •10. Subjects with any of the following clinical laboratory tests results at screening:
• •a Aspartate aminotransferase (AST) \> 1.5 × the upper limit of normal (ULN)
• •b Alanine aminotransferase (ALT) \> 1.5 × ULN
• •c Serum creatinine \> 1.2 × ULN; or creatinine clearance \< 60 mL/min (calculated by the Cockcroft-Gault)
• •\*The clinical laboratory tests of hematology, blood biochemistry, or urinalysis could be allowed repeat once if Investigator considers it necessary
• •11. Subjects whose QTcF interval prolongation at screening (male: QTcF interval ≥ 450 ms, female: QTcF interval ≥ 470 ms)
• •12. Blood donation or blood loss more than 400 mL within 3 months before the screening visit
• •13. Subjects with a known history of drug abuse within 2 years before the screening visit; or positive drug abuse at screening
• •14. Weekly alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of spirit with the alcohol content of 40% or 150 mL of wine) in any week within the past 3 months before the screening visit; or intake of alcohol-containing products within 48 hours before the first dose, or cannot abstain from any alcohol product during the study, or positive breath alcohol test at screening or check-in (Day -1）
• •15. Smoking history (\> 5 cigarettes per day) within 3 months before the screening visit, or cannot abstain from any tobacco products during the study, or positive urine nicotine test before randomization
• •16. Excessive drinking of tea, coffee, or caffeine-containing beverage (at least 8 cups per day, 1 cup = 250 mL) any day within 3 months before screening; intake of rich caffeine- or xanthine-containing food or drinks that may produce caffeine or xanthine after being metabolized (eg, coffee, tea, chocolate, cola drinks) within 48 hours before the first dose
• •17. Any marketed medication (prescription and nonprescription drugs) within 14 days before the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (excluding oral contraceptives and low dose paracetamol at the discretion of the Investigator, or topical ointments at the discretion of the Investigator)
• •18. Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing
• •19. Use of herbal medicines, dietary supplements and vitamin within 14 days before the first dose(permissible at the discretion of the Investigator)
• •20. Subjects who have a major surgery within 3 months before the first dose or who plan to undergo surgery during the study
• •21. Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody