Canadian pharmaceutical development company Algernon Pharmaceuticals has commenced screening subjects for its Phase 1 clinical study of an intravenous formulation of DMT – AP-188 – in the Netherlands.
The trial will be conducted at the Centre for Human Drug Research (CHDR) in Leiden.
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 which have never been studied clinically.
Several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings will also be recorded.
CEO of Algernon Pharmaceuticals, Christopher Moreau, commented: “We are very excited to be initiating our DMT clinical stroke research program with our Phase 1 study at CHDR in the Netherlands.
“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.”
The first part of the study will use a single-escalating dose design, aimed at identifying a safe and tolerable dose that will not produce psychedelic effects, while the second part will test the effects of repeated administrations of this dose.
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.
Since there have already been several Phase 1 studies successfully conducted on DMT, the Company is not anticipating any serious adverse events or safety issues arising from its study.
The resulting data generated will help the Company to plan both its Phase 2 acute stroke and rehabilitation studies more effectively.
The company’s decision to investigate DMT and move it into human trials for stroke is based on multiple independent, positive preclinical studies demonstrating that DMT, at a sub-psychedelic dose, helps promote structural and functional neuropasticity.
These are key factors involved in the brain’s ability to form and reorganise synaptic connections, which are needed for healing following a brain injury.
The company plans to open enrollment shortly and dose the first subject of the study in December 2022.
