Interventional, randomised, double-blind, placebo-controlled, multiple-ascending-dose, first-in-human trial to determine the safety and tolerability of the MEK1/2 inhibitor EDV2209 in patients withSubarachnoid Haemorrhage – SAH - EDV2209_01

Edvince AB0 个研究点目标入组 27 人开始时间: 2024年6月26日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Male or female patients aged 18-80 years (both inclusive), Moderate or severe SAH diagnosed with CT and caused (or suspected to be caused) by a ruptured saccular aneurysm with symptoms less than 8 hours, Intracerebroventricular access obtained within 8 h from start of symptoms, A WFNS score 1-5, assessed at any time after SAH diagnosis, but before first dose of IMP, Informed consent obtained from a trial guardian prior to initiation of any trial-related procedures.

•The SAH due to other causes (e.g., trauma, rupture of fusiform or mycotic aneurysms), Intraventricular or intracerebral blood, in the absence of subarachnoid blood, Expected survival < 48 hours, Any severe or unstable chronic or acute concomitant condition, which, in the opinion of the PI/delegate, would affect the assessment of the safety of the IMP, Any known or CT evidence of previous major cerebral damage or preexisting cerebrovascular disorders, which in the opinion of the PI/delegate may affect the accurate diagnosis and evaluation of SAH, Participation in any other clinical trial with an experimental drug within the last 12 weeks, Known allergy to the IMP or its constituents, Female patients who are pregnant or breastfeeding. Women of childbearing potential must have a negative plasma or urine pregnancy test at screening

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