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.