Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) told investors it had started screening people to take part in its Phase 1 clinical study of an intravenous formulation of AP-188, or DMT to treat stroke, which will take place at the Centre for Human Drug Research (CHDR) in Leiden in the Netherlands.
The company said it aimed to start enrolling people shortly and dose the first subject in December this year.
"We are very excited to be initiating our DMT clinical stroke research program with our Phase 1 study at CHDR in the Netherlands,” said Christopher J. Moreau, the CEO of Algernon Pharmaceuticals, in a statement.
"The preclinical data shows that DMT promotes the production of brain-derived neurotrophic factor which is an important part of the brain’s recovery process after an injury like a stroke," he added.
READ: Algernon Pharmaceuticals granted approval for Phase 1 human DMT study for treatment of stroke in the Netherlands
N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug, which produces effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin.
The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion, for durations that have never been studied clinically, said Algernon.
It will involve two parts. The first will use a single-escalating dose design, aimed at identifying a safe and tolerable level that will not produce psychedelic effects, while the second part will test the effects of repeated administrations.
There will be up to 60 healthy volunteers enrolled across the two parts of the study which will include both psychedelic experienced and psychedelic naïve patients.
Algernon is a drug-repurposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications.
Contact the writer at giles@proactiveinvestors.com