6 results
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…
Primary objective: The primary purpose of the research is to determine the difference in pain experience during rest, measured by means of an 11-point Numerical Rating Scale (NRS), between peroperatieve Local infiltration with Analgesics (LIA) vs.…
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.
• To assess contraceptive efficacy, vaginal bleeding patterns (cycle control),general safety and acceptability of the NOMAC-E2 COC in a large group ofwomen aged 18-50 years.
To evaluate the effects on ovarian function with the NOMAC/E2 COC in a group of women aged 18-35 years.
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…