Clinical Trial for PB-119 in Healthy Subjects (Phase I)

Inclusion criteria

• Male or female volunteers, ages: between 18-45;
• Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2
• Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant;
• Read, agree, and sign the informed consent;
• Be able to communicate with the investigator and finish the study according to the protocol.

Exclusion criteria

（anyone or more of the following):

• Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);
• Experiencing clinically significant disease or surgery within 4 weeks before the study;
• Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder;
• Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney);
• Fever history within 3 days of the screening;
• Clinical significant abnormality found in laboratory tests (blood, urine routine test) within 2 weeks before study;
• ECG or vital signs is clinically significant abnormality as judged by the Investigator( systolic blood pressure <90mmHg or ≥140mmHg; diastolic blood pressure<60mmHg or ≥90mmHg; heart rate <50bpm or >100bpm);
• Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive;
• Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol, in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port wine;
• Addicted to cigarette, tea, coffee or drugs;
• Have specific requirement for diets (or allergic to any food);
• Have been administered in the past 2 weeks with any drug (such as antibiotics, anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate to be used in this study;
• Participated in any clinical trial in the past 3 months;
• Donated blood of more than 360 ml in the past 3 months;
• Plan to be pregnant herself or his spouse in the next 6 months;
• Females administered with any oral contraceptive 30 days before the study or during the study;
• Females dosed with long acting estrogen or progestin (injections or implant) 6 months before the study or during the study;
• Females at childbearing age that had unprotected intercourse 14 days before the study or will have during the study;
• Female who is pregnant or nursing;
• Anybody who might not be able to complete the study, or considered not appropriate by the investigator.