5 results
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…
This study aims to investigate whether the definition of a fixed volume limit of 500 ml can be changed to a bladder volume limit adapted to each individual*s own maximum bladder capacity. It is expected that this change in definition will lead to…
Part A: To determine the recommended phase 2 dose and schedule of the RMC-4630 and LY3214996 combination in patients with KRASm advanced CRC, NSCLC and PDAC.Part B: To determine the safety and tolerability of RMC-4630 in combination with LY3214996…
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…