Current projects

Safety en tolerability of EA-230

Aim and methods: The goal of this randomized, double-blind, placebo-controlled study is to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of the novel compound EA-230, a newly developed compound which is derived from the human chorionic gonadotropin hormone (hCG). This iss conducted in a phase 1 trial followed by a phase 2a trial using the experimental human endotoxemia model in 36 healthy human volunteers.


 

The model

During experimental human endotoxemia, we challenge healthy human subjects intravenously with purified endotoxin (lipopolysaccharide (LPS)). read more

The model

During experimental human endotoxemia, we challenge healthy human subjects with purified endotoxin (lipopolysaccharide (LPS)) intravenously which induces a short-lived, well-tolerated and controlled systemic inflammatory response, similar to that observed during sepsis. The human endotoxemia model can be conducted in a highly standardized and reproducible manner, using a carefully selected homogenous study population.

The model has proven to be safe, well-tolerated and without any known long-term health risks for the participating subjects. Intravenous endotoxin administration elicits a transient and controlled systemic inflammatory response, clinically characterized by an increase in core temperature of approximately 1.5–2 °C, flu-like symptoms (such as headache, chills, fatigue, myalgia, backache, and nausea) during 2–4 h, as well as hemodynamic alterations (tachycardia, tachypnea, and decrease in blood pressure).