6 results
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…
The primary objective of this study is to assess the negative predictive value of a Skin Prick Test protocol in subjects with clinical CMA and/or RA.
Primary: To evaluate the tolerability and safety of the treatment with rhC1INH (conestat alfa) on top of Standard Care, for patients with pre-eclampsia.Secondary: To evaluate the efficacy of treatment with rhC1INH (conestat alfa) on top of Standard…
The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (KLS Martin Group) in vivo, using mRSA, over 10 years. Furthermore, the safety and usability of the tantalum markers and the marker inserter…
The primary objective of this exploratory study is to test if prophylactic use of conestat alfa decreases the frequency of angioedema attacks in patients with InH-AAE. As secondary objectives, effects on disease severity, quality of life and drug…