A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers

Exclusion Criteria

• •1. Subject has a total IgG level of \< 700mg/dL at screening.
• •2. Subject has an active infection or has had a serious infection within 6 weeks prior to Day -1 or infection requiring oral anti-infective agents within 2 weeks prior to Day-1, or subject had a febrile illness or symptomatic, viral, bacterial, or fungal infection within 1 week prior to admission (Day -1).
• •3. History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
• •4. Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
• •5. Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
• •6. Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
• •7. Positive HIV test result at screening.
• •8. Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
• •9. Subject has a positive T-cell interferon-γ release assay (TIGRA) result
• •10. Subjects who had immunization within 4 weeks before screening; or subjects who plan to have immunization during the study and within 12 weeks after dosing of the study drug.
• •11. For female subjects, positive pregnancy test at screening or Day -1, or planning to become pregnant from screening until 90 days after the dosing of the study drug.
• •12. Lactating female subjects.