The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants

Inclusion criteria

• Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
• Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
• Males and female subjects between 18-50 years (Both inclusive). Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
• Physical condition and vital signs: Normal or abnormality has no clinical significance.

Exclusion criteria

• Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product;
• The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
• Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week: 1 unit = 285 ml of beer; or the equivalent of 25 ml of spirit, or 100 ml of wine )
• Subjects who donated blood or bleeding profusely (> 400 mL) in the 3 months preceding study screening.
• Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs, include a history of frequent nausea or vomit causes by any etiology.
• History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc.
• Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
• History of having any special food (including dragon fruit, mango, grapefruit, etc.), strenuous exercises, or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 7 days prior to screening.
• Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition.
• Presence of clinically significant abnormalities in ECG or QTcF>450ms
• Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.