A Study of OsrHSA in Adult Healthy Male and Female Volunteers

Inclusion Criteria

Subjects must meet all the following criteria to be enrolled in the trial

• Able to understand and willing to sign the ICF
• Healthy male and female subjects, 18-55 years of age, non-smokers, or subjects must have been non-smoking for at least 3 months prior to their screening visit.
• Has adequate venous access
• With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination,vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated measurements.
• Subjects must have adequate organ function according to the following laboratory values:
• Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count ≥100,000/mm3)
• Adequate liver function [alanine aminotransferase (ALT) to ≤1.5× upper limit normal (ULN) and alkaline phosphatase to ≤1.5× ULN, total bilirubin ≤1.5 mg/dL]
• Adequate renal function creatinine clearance ≥60 mL/min based on Cockcroft- Gault equation, or serum creatinine level ≤1.5 times the ULN.
• Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH > 40mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman of childbearing potential, have a negative urine pregnancy test at screening:
• Practicing abstinence
• If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 30 days after the administration of the investigational product:
• simultaneous use of intra-uterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
• simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
• simultaneous use of diaphragm with intravaginally applied spermicide and male condom for the male partner, starting at least 21 days prior to study drug administration.
• Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 90 days after their dose and must not donate sperm during their study participation period:
• Simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
• Simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.
• Body mass index (BMI) 18-30 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Blood pressure ≤ 139/89 mm Hg.
• Subjects are able to follow the study protocol and complete the trial.
• At least 25% of the enrolled subjects will be of Asian descent, defined as Chinese, Japanese, Korean, Vietnamese, Hmong, and their offspring.

Exclusion Criteria

Subjects who meet any of the following criteria cannot be enrolled:

• History of severe infection within 4 weeks to dosing.
• Signs and symptoms of any active infection regardless of severity within 2 weeks prior to dosing.
• Meals & Dietary Restrictions: No seafood or high-fat food will be s