Canadian clinical-stage psychedelics company Algernon Pharmaceuticals Inc. AGNPF has begun screening subjects for its Phase 1 clinical study on the IV formulation of its DMT compound AP-188 in the Netherlands.
CEO Christopher J. Moreau said the company is thrilled to initiate its clinical stroke research program with this study as “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 trial, to be conducted at the Centre for Human Drug Research (CHDR) in Leiden, is expected to open enrollment shortly and dose the first participant in December 2022.
The first part of the study will use a single-escalating dose design to identify a safe and tolerable dose that will not produce psychedelic effects, while the second half will test the effects of repeated administrations of that same dose.
Up to 60 healthy volunteers will be enrolled across the two parts of the study and include both psychedelic-experienced and psychedelic-naïve patients.
The purpose is meant to identify the safety, tolerability and pharmacokinetics of AP-188 when administered as an intravenous bolus followed by prolonged infusion for durations as yet never tested in humans.
The trial will record measurements of biochemical markers and EEG readings to further assess pharmacodynamic measures potentially associated with neuroplasticity.
Algernon plans to use the data to plan its Phase 2 clinical trials for acute stroke and rehabilitation. The company has already filed patents for novel salt forms of DMT (pamoate and nicotinate) plus formulation, dosage and method of use claims for ischemic stroke. It has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.
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