A Phase I Study of SNH-119014 in Healthy Volunteers

Inclusion Criteria:

• Healthy male or female subjects;

• 18-45 years of age, inclusive;

• Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m2.

• Must provide written informed consent.

Exclusion Criteria:

• History of or current clinically significant circulatory system, endocrine system,nervous system, digestive system, respiratory system, urinary system, ophthalmology,hematology, immunology, psychiatry disorder, as judged by the investigator；

• Subjects who have undergone major surgery 6 months prior to screening or who plan toundergo surgery during the study period;

• Clinically significant abnormal physical examination, vital signs, chest X-ray,laboratory tests during the screening period as judged by the investigator;

• Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalitiesduring the screening period as judged by the investigator;

• Subject has a positive test result for hepatitis B surface antigen (HBsAg),hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or humanimmunodeficiency virus (HIV) antibody at screening;

• Subjects who have a known chronic liver disease, or who have clinically significantabnormal liver function test results during the screening period;

• History of urinary system diseases.

• History of dysphagia or any gastrointestinal disorder affecting drug absorption.

• History of malignancy.

• History of severe allergies or allergic to the study drug or any of its components.Serious adverse reaction or hypersensitivity to any drug or the formulationexcipients.

• Failure to follow a consistent diet.

• Over 5 cups (200 ml per cup) of tea, coffee, or caffeinated beverages were consumeddaily during the 3 months prior to screening.

• Consumption of a specific diet (e.g. grapefruit and grapefruit-containing products,chocolate, any food containing caffeine), or vigorous exercise, or other factorsaffecting drug absorption, distribution, metabolism, excretion within 48 hoursbefore the dose of study drug.

• Subjects who have taken any drugs that alter the activity of liver enzymes and/ortransporters within 28 days prior to screening.

• Females who are pregnant or lactating and subjects who are unable to use one or morenonpharmacological contraceptives.

• Subjects who have taken any prescribed or over-the-counter drug or herbal remediesor nutraceutical product within 14 days before the dose of study drug.

• Subjects who smoked more than 5 cigarettes per day during the 3 months prior toscreening, or who cannot accept a smoking ban throughout the study.

• Alcohol intake >14 units per week within 6 months prior to screening (1 unit isequal to 14g of alcohol such as 360mL of beer, 45mL of 40% spirit, 150mL of wine, ora confirmed positive alcohol breath test, or alcohol prohibition is not acceptablethroughout the study.

• History of drug abuse in the past 1 year prior to screening, or a confirmed positivedrugs of abuse test result before randomization.

• Subjects who plan to conceive or donate sperm or eggs during the study or within 3months after completion of study.

• Subjects has received study drug in another clinical study within 3 months beforethe dose of study drug.

• Subjects who have donated blood or loss ≥400 mL of blood within 3 months before thedose of study drug, or who plan to donate blood or blood components during the studyor within 3 months after completion of study.

• Subjects who have received a live attenuated vaccine within 28 days before the doseof study drug.

• Subjects who cannot tolerate venipuncture, or those with a history of needlefainting or blood fainting.

• In the opinion of the investigator, the subject is not suitable for entry into thestudy.