Astrocyte Pharmaceuticals has commenced a Phase lB trial of AST-004 as an extended infusion for the treatment of stroke and traumatic brain injuries.
The trial has been designed to evaluate AST-004’s safety, tolerability, and pharmacokinetics and pharmacodynamics when given as a loading dose followed by a nonstop infusion over six hours.
Data from the trial is set to support Astrocyte to begin a Phase ll study in future.
The adaptive-design Phase IB trial will enrol healthy subjects and will be carried out for a period of four to six months.
It will be conducted at the QPS clinical research centre in Groningen, Netherlands.
The trial has been jointly financed by the Medical Technology Enterprise Consortium (MTEC) and the US Army Medical Research and Development Command (USAMRDC) of the US Department of Defense.
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It follows an announcement made by Astrocyte in June last year regarding the dosing of the first patient in the first-in-human Phase I AST-004-1-02 trial of AST-004 to treat stroke and traumatic brain injury.
AST-004, an investigational small molecule adenosine A3/A1 receptor agonist, demonstrated improved cerebroprotective data in preclinical trials.
Astrocyte Pharmaceuticals Clinical Development Operations vice-president Lisa Manna said: “Astrocyte is committed to developing innovative therapies that treat brain injuries and improve the lives of patients.
“The initiation of this Phase lB study is an important step forward in the development of AST-004 supporting multiple indications, and we look forward to continuing the clinical development of this novel and promising therapy.”