The study will evaluate the safety and pharmacokinetics of rVIIa-FP in comparison to placebo, in healthy volunteers.
Due to albumin’s inherently long half-life, high potential for tolerability, known mechanism of clearance and low potential for immunogenic reactions, it is employed in CSL Behring’s albumin fusion technology.
The company’s rVIIa albumin fusion protein is expected to exhibit a good tolerability profile and improved pharmacokinetics that may enable prophylaxis.
The rVIIa-FP has received European and the US FDA orphan drug designation.