Astrocyte Pharmaceuticals has dosed the first participant in the first-in-human Phase I AST-004-1-02 clinical trial of AST-004, being developed as a potential acute treatment for stroke and traumatic brain injury (TBI) victims.
The investigational therapy is also being advanced as a chronic treatment for neurodegenerative diseases such as Alzheimer’s.
The trial will enrol up to 52 healthy subjects of the age 18 to 55 years.
It is partly funded by the Medical Technology Enterprise Consortium in cooperation with the United States of America Department of Defense’s US Army Medical Research and Development Command.
Assessing the safety, tolerability and pharmacokinetic profile of AST-004 in healthy participants is the primary objective of the trial.
It will evaluate multiple dose levels of AST-004 over six months at a clinical research site in Kistarcsa, Hungary.
In preclinical animal models, AST-004 showed to preserve up to 45% more brain tissue in a non-human primate model of stroke, beyond that of reperfusion standard of care.
Astrocyte Clinical Development Operations vice-president Lisa Manna said: “AST-004 demonstrated significant safety in the required regulatory animal studies, and we look forward to taking this next step of understanding its safety and pharmacokinetics in humans.”
On establishing that AST-004 is well tolerated with a favourable safety profile in the trial, the company will advance to Phase II trials to assess its efficacy to treat stroke and TBI patients.
A clinical-stage, drug discovery and development company, Astrocyte works on establishing the cerebroprotective benefits of boosting astrocyte function and progressing breakthrough therapeutic agents to treat brain injury due to stroke, traumatic brain injury, concussion and neurodegenerative ailments.