Natrunix Safety PK Study in Healthy Volunteers

Exclusion Criteria

• •1. Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• •2. Uncontrolled or significant cardiovascular disease, including:
• •* A myocardial infarction within the past 6 months.
• •* Uncontrolled angina within the past 3 months.
• •* Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Class II or higher.
• •* Uncontrolled hypertension (blood pressure \>160 mm Hg systolic or \>100 mm Hg diastolic).
• •3. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• •4. Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
• •5. Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, cerebrovascular accident within three months, ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participating in the trial.
• •6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• •7. Abnormal ECG with any clinically significant findings or with QTc \> 470 ms.
• •8. Infection requiring treatment with antibiotics within 3 weeks prior to screening.
• •9. Infectious disease:
• •• Positive HIV, RPR, Hepatitis B or C, TB (QuantiFERON-TB Gold (QFT)/ IGRA)
• •10. History of immunodeficiency.
• •11. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
• •12. Major surgery within 28 days prior to Day 0.
• •13. History of progressive multifocal leukoencephalopathy (PML) or other demyelinating disease.