A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers

Exclusion Criteria

• •Abnormal screening and baseline blood and urine tests determined to be clinically significant by the Investigator.
• •Hematologic or hepatic enzyme laboratory values that were outside the normal range.
• •History of severe allergic or anaphylactic reactions.
• •History of any clinically-significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, and/or history of seizure disorder.
• •A family history of MS in a first-degree relative.
• •A fever (body temperature \>38°C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to Day 1.
• •Abnormal ECG values as determined by the Investigator.
• •Positive test result for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody.
• •Female subjects who are considering pregnancy, currently pregnant or breastfeeding.
• •Subjects who received a tattoo or body piercing (including earring) within 60 days of baseline or subjects who are considering getting a tattoo or body piercing (including earring) in the next 60 days.
• •Use of any prescription or non-prescription medication that could inhibit bone marrow or liver function.
• •Any previous treatment with any interferon product.
• •Participation in any other investigational drug study within the 4 weeks prior to Day 1 or within 5 half-lives of the investigational treatment, whichever is longer.
• •Treatment with the Flu Vaccine within 1 week prior to Day 1.