Study of OsrhAAT or Placebo in Healthy Volunteers

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

1. Able to understand and willing to sign the ICF
2. Healthy subjects, male or female, non-smokers, 18-55 years of age
3. No significant medical history, and in good health as determined by detailed medicalhistory (neurological, endocrinal, cardiovascular, pulmonary, hematological,immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease),full physical examination, vital signs, 12-lead electrocardiogram (ECG), urinalysisand laboratory tests at screening. For eligibility purposes, abnormal laboratory orvital signs results may be repeated once if abnormal result is observed at the initialreading. Moreover, abnormalities found in the ECG may need to be confirmed by repeatedmeasurements.
4. Adequate organ function according to the following laboratory values:

• Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count ≥100,000/mm3).
• Alanine aminotransferase (ALT) 7-56 units per liter of serum ( or institutionalequivalent), AST 5-40 units per liter of serum (or institutional equivalent),alkaline phosphatase 20-140 units per liter of serum (or institutionalequivalent), total bilirubin 0.1-1.0 mg/dL (or institutional equivalent) andcreatinine clearance (Cockcroft-Gault equation) ≥90mL/min.

5. Female of non-childbearing potential (i.e., physiologically incapable of becomingpregnant, including any female who is 1 year of post-menopausal with a FSH > 40mIU/mL,or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy ortubal ligation]) or agree to one of the following to prevent pregnancy and, if a womanof childbearing potential, have a negative pregnancy test at screening:

• Practicing abstinence which is the preferred and usual lifestyle of the subject
• If a sexually active woman of childbearing potential (sexually active with anon-sterile male partner) agrees to prevent pregnancy by using double methods ofcontraception as follow until 180 days after the administration of theinvestigational product:

1. Simultaneous use of intra-uterine contraceptive device, placed at least 4weeks prior to study drug administration, and condom for the male partner.
2. Simultaneous use of hormonal contraceptives, starting at least 4 weeks priorto study drug administration and must agree to use the same hormonalcontraceptive throughout the study, and condom for the male partner.
3. Simultaneous use of diaphragm with intravaginally applied spermicide andmale condom for the male partner, starting at least 21 days prior to studydrug administration. Male subjects who are not vasectomized for at least 6months and who are sexually active with a non-sterile female partner mustagree to use double methods of contraception below from the first dose ofrandomized study drug until 120 days after their dose and must not donatesperm during their study participation period:
4. Simultaneous use of a male condom and, for the female partner, hormonalcontraceptives (used since at least 4 weeks) or intra-uterine contraceptivedevice (placed since at least 4 weeks)
5. Simultaneous use of a male condom and, for the female partner, a diaphragmwith intravaginally applied spermicide
6. Body mass index (BMI) 18.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and

• 45.0 kg for females

7. Blood pressure ≤ 139/89 mm Hg
8. Able to follow the study protocol and complete the trial

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

1. History of severe infection within 4 weeks prior to administration; signs and symptomsof any active infection regardless of severity within 2 weeks prior to administration.
2. History of hypersensitivity to OsrhAAT or any excipient or similar drugs
3. Known History of hypersensitivity to rice
4. Use of any prescription drugs, herbal supplements, or nonprescription drugs, includingoral antihistamines (for seasonal allergies), within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplementswithin 1 week prior to study drug administration, unless, in the opinion of theInvestigator and the Sponsor, the medication will not interfere with the study.Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophenmay be used, but must be documented in the Concomitant medications/Significantnon-drug therapies page of the source data. Any questions of concomitant medicationsshould be directed to the Sponsor.
5. Participation in a clinical research study involving the administration of aninvestigational or marketed drug or device within 30 days prior to the first dosing,administration of a biological product in the context of a clinical research studywithin 90 days prior to the first dosing, or concomitant participation in aninvestigational study involving no drug or device administration.
6. Donation of blood 12 week prior to dosing
7. Pregnant, or nursing females
8. A history of psychiatric and psychological condition that, in the judgment of theInvestigator, may interfere with the planned treatment and follow-up, affect subjectcompliance or place the subject at high risk from treatment-related complications
9. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of aQTc interval >450 milliseconds [ms], Bazett Formula: QTc=QT/RR0.5）
10. Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled, inthe judgement of the Investigator.
11. Known infection with human immunodeficiency virus (HIV) and a cluster ofdifferentiation 4 (CD4) count that is unknown or documented to be < 350 cells/mm3within 12 months, or an Acquired Immune Deficiency Syndrome (AIDS)-defining illness
12. Known history of severe IgA deficiency
13. Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior tostudy drug administration. Seasonal influenza vaccines for injection are generallykilled virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist®) are live attenuated vaccines and are not allowed
14. Receipt of an immunoglobulin or blood product 90 days prior to dosing
15. History of consuming more than 14 units of alcoholic beverages per week or ofalcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). Consumed > 3 (male) or 2 (female) units of alcohol as determined by blood alcohol testing atscreening
16. History of significant drug abuse within one year prior to screening
17. Positive urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids,cocaine, cotinine and opiates)
18. Any reason which, in the opinion of the Investigator, would prevent the subject fromparticipating in the study