4 results
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
The purpose of this study is to determine the need for thromboprofylaxis in patients being treated in a below-knee plaster cast after trauma of a lower extremity and if there is, to assess if both of the two tested prophylactic treatments are suited…
2.1.1 Primary Objective1.Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg.Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20…
Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts):Primary:• To evaluate the preliminary efficacy of XB002 when administered alone and in combination therapy by determining the ORR per RECIST 1.1 (or other applicable response…