Comparison Study of PF530 and Betaferon in Healthy Subjects

This is an interventional treatment trial for Multiple Sclerosis Read More

Inclusion Criteria:

• Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
• Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
• Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
• Able to understand and sign the written Informed Consent Form

Exclusion Criteria:

• Female subjects who are pregnant or lactating.
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
• Previous treatment with any interferon product, including investigational use.
• Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
• Positive screening test for human immunodeficiency virus (HIV).
• Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen [HBsAg] at Screening). Participants with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
• History of epilepsy, seizure disorder or any unexplained black-outs.
• History of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (NSAID) that would preclude the use of at least 1 of these during the study.
• History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
• History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
• History of tobacco use less than or equal to 6 months prior to Screening.
• A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
• Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
• Use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the Sponsor.