4 results
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
The primary objective:To demonstrate that CT-P10 is similar to Rituxan in terms of pharmacokinetics as determined by AUCtau and CmaxSS at Cycle 4 and maximum serum concentration at steady state The secondary objective:Efficacy: the primary endpoints…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…