Phase I BP Interferon (IFN) Beta-001

Exclusion Criteria

• •History of major renal, hepatic, immunological, haematological, gastrointestinal, genitourinary, neurological, or rheumatological disorders
• •Active diseases of any type, even if mild, including inflammatory disorders and infections.
• •Pregnant or lactating women or women contemplating becoming pregnant during study. Female subjects of child-bearing potential who did not practice efficient contraception during the study. A pregnancy test in blood was performed at screening and before each period with β-human chorionic gonadotropin for females of child-bearing potential. If pregnancy test was positive, the subject had to be immediately excluded from study and followed until delivery
• •History of severe allergy or of asthma at any time.
• •History of cardiovascular dysfunction
• •Hypertension
• •Sick sinus syndrome or known long QT syndrome
• •Presence of QTc  \> 440 msec or pronounced sinus bradycardia (\<40 bpm/min), even if elicited by sport
• •Dark skin preventing local tolerance assessment or abnormal cutaneous reaction e.g. urticaria or papular dermographism
• •Intense sport activities.
• •Any clinically significant laboratory value on screening that were not within normal range on single repeat
• •Positive hepatitis B \& C antigen screen
• •Positive HIV antibody screen or screen not performed
• •Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study
• •Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
• •History of hypersensitivity to any drug if considered as serious
• •History of alcohol or drug abuse
• •Positive qualitative urine drug test at screening
• •Use of any medication in 2 weeks prior to study and throughout study, including aspirin or other over-the-counter preparation.
• •Blood (500 mL) donation or hemorrhage during the previous three months
• •Participation in a clinical trial in the previous 3 months
• •Smoking
• •Consumption of a large quantity of coffee, tea or equivalent
• •Present consumption of a large quantity of alcohol or wine or equivalent
• •Psychological status which could have had an impact on subject's ability to give informed consent or behavioral tests
• •Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject