6 results
See protocol page 12The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing system and to assess long-term device performance.
To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.
Primary Objective:1. To assess the safety and tolerability of single escalating doses of Adrecizumab in healthy male volunteers during experimental endotoxemia.Secondary Objectives:2. To determine the pharmacokinetics of single escalating doses of…
The primary objectives of this study are to assess whether there is transfer of CZP into breastmilk of lactating mothers who are receiving an established dosing regimen of CZP by evaluatingthe concentration of CZP in mature breast milk, and to…
The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…
Patients will be evaluated for safety and tolerability of the therapy, but also for signs of clinical efficacy. As long as the patients are on the ICU, measurements of clinical signs and laboratory data will be collected for safety reasons and for…