phase i bp interferon (ifn) beta-004

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: phase i study aiming at: * establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation biopartners ifn beta-1a without albumin (hsa-free solution in pre-filled syringes) at 18 miu; * investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different i.v. formulations: biopartners ifn beta-1a without albumin (hsa-free solution in pre-filled syringes), biopartners ifn beta-1a with added albumin (hsa+), and rebif® from merck-serono, a registered ifn beta-1a solution containing hsa; * establishing the steady state pharmacokinetic profile of biopartners ifn beta-1a in hsa-free solution after 4 subsequent s.c. doses of 18 miu given at 48 hour intervals against rebif® using the same regimen.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects aged between 18 and 45 years * weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body mass index (bmi) was between 18 and 29 kg/m2 * absence of significant findings in the medical history and physical examination * absence of significant laboratory abnormalities as judged by the investigator. * 12-lead ecg without significant abnormalities * negative urine drug screen 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