A Phase I Study of ICP-022 in Healthy Subjects

Inclusion Criteria:

• Healthy male subjects age ≥18 and ≤55 years

• Body mass index ≥19 and ≤31 kg/m2, with minimum body weight of 50kg

• No clinically significant findings in the medical history and physical examination,especially with regard to the respiratory, heart, immune system, pancreas, liver, bileand gastrointestinal systems

• No clinically significant laboratory values and urinalysis, unless the investigatorconsiders any abnormality to be clinically irrelevant;

• Subjects with a partner of child-bearing potential must be willing to use an approvedform of contraception with a failure rate of <1%. Subjects must be willing to use acondom during sexual intercourse whether or not their partner is of child-bearingpotential from screening until 90 days after their final study visit.

• Normal electrocardiogram (ECG), blood pressure, and heart rate, unless theinvestigator considers any abnormality to be clinically irrelevant

• Informed consent must be obtained in writing for all subjects personally at enrollment

Exclusion Criteria:

• Subjects with medically important events

• Having 1st degree relative with coronary heart disease at age <60

• Using of prescription drugs including but not limited to those known to interfere withmetabolism of drugs within 30 days prior to dosing

• Exposure to any other medication, including over-the-counter medications, herbalremedies and vitamins for at least 14 days before randomization (except paracetamol

• Participation in another study with any investigational drug in 30 days or fivehalf-lives (whichever is longer) preceding the study

• Current smoker, defined as more than 10 cigarettes or equivalent per day before thebeginning of the study (participants currently smoking ≤10 cigarettes daily and ableto completely stop smoking during the study from screening until follow-up areeligible)

• Symptoms of a clinically significant illness in the 3 months before the study

• Presence or sequelae of respiratory, gastrointestinal, immune system, heart, liver orkidney disease, including asymptomatic unconjugated hyperbilirubinemia or asthma, orother conditions known to interfere with the absorption, distribution, metabolism, orexcretion of drugs

• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease

• Hemorrhoids or anal diseases with regular or recent presence of blood in feces

• History of immediate hypersensitivity to any medications or any food allergy, andacute phase of allergic rhinitis in the previous 2 weeks before randomization

• Blood or plasma donation of more than 500 mL during the previous 2 months beforerandomization and/or more than 50 mL in the 2 weeks prior to screening, or plan todonate any additional blood for 12 weeks after completing the study

• Subjects with a positive quantiFERON® test at screening or within 6 months prior toDay 1

• Positive test for human immunodeficiency virus (HIV)

• Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), unlesscaused by immunization

• Positive urine drug screen within 1 year before randomization

• Positive alcohol screen or active alcoholism

• Mental condition rendering the subject incapable to understand the nature, scope, andpossible consequences of the study

• Subject has difficulty swallowing or is unable to swallow a tablet

• Unlikely to comply with the clinical study protocol eg, uncooperative attitude,inability to return for follow-up visits, and improbability of completing the study

• Investigator, or any sub-investigator, research assistant, pharmacist, studycoordinator, other staff directly involved in the conduct of the protocol, or firstdegree relative thereof

• Subject requires anticoagulation treatment in the past 30 days

• Subject with anemia of any kind

• Subject with pancreatic abnormality of any kind, or elevated Lipase or Amylase >ULN