PK/PD of EA-230 During Endotoxemia

Summary

EA-230 is a newly developed synthetic compound with anti-inflammatory properties. Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation resulting from a variety of causes such as surgery, trauma, infection, irradiation and others. Although previous studies in healthy volunteers have shown an excellent safety profile, the safety and tolerability of higher doses administered per continuous infusion need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be further elucidated before a phase II trial in patients can be commenced.

Timeline

Start

2015-02

Primary completion

2015-07

Completion

2015-12

Publications

• van Groenendael R, Kox M, Leijte G, Koeneman B, Gerretsen J, van Eijk L, Pickkers P. A randomized double-blind, placebo-controlled clinical phase IIa trial on safety, immunomodulatory effects and pharmacokinetics of EA-230 during experimental human endotoxaemia. Br J Clin Pharmacol. 2019 Jul;85(7):1559-1571. doi: 10.1111/bcp.13941. Epub 2019 May 23.

Drugs

Indications

No indication recorded.