Astrocyte Pharmaceuticals has announced the initiation of a Phase 1b study of its lead cerebroprotective candidate, AST-004, as an extended infusion in healthy volunteers. This adaptive-design clinical study will be conducted over the next four-to-six months at the QPS clinical research site in Groningen, The Netherlands.
AST-004 is a small molecule adenosine A3/A1 receptor agonist that has consistently shown promising cerebroprotective results in preclinical studies, as per a press release from Astrocyte. The drug is intended to provide cerebroprotective effects in stroke and traumatic brain injuries.
A Phase 1a study, completed in 2022, with single ascending 10-minute bolus doses of AST-004 showed no significant adverse effects or safety signals.
The company’s Phase 1b study will assess the safety, tolerability, and pharmacokinetics and pharmacodynamics of AST-004 administered as a loading dose followed by a continuous infusion over six hours, and provide important data to support Astrocyte’s future Phase 2 programme, the release adds.
“Astrocyte is committed to developing innovative therapies that treat brain injuries and improve the lives of patients,” said Lisa Manna, Astrocyte’s vice president of Clinical Development Operations. “The initiation of this Phase 1b 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.”
The study is funded in part by the Medical Technology Enterprise Consortium (MTEC), in cooperation with the US Army Medical Research and Development Command (USAMRDC) of the United States of America Department of Defense.