Phase I study aiming at:
- assessing the absolute bioavailability, pharmacokinetic profile, and dose
proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after
i.v. and s.c. administration as well as the pharmacodynamic profile to create the link
with available surrogate markers investigated with both formulations used clinically,
lyophilisate with HSA (HSA+) and solution without HSA (HSA-);
- gathering further information on safety and tolerability of interferon beta-1a over dose
range,including local and systemic tolerance, body temperature, vital signs, and a
battery of exploratory sickness behavior tests.