A clinical trial investigating the safety and tolerability of a novel formulation of 5-MeO-DMT in psychedelic-naive subjects has dosed its first cohort of volunteers.
Carried out by Beckley Psytech, the Phase 1 clinical trial investigating the efficacy of a novel, intranasal formulation of 5-MeO-DMT, is the first to measure the pharmacokinetics and metabolism of the molecule.
The study, which is being conducted as part of an ongoing collaboration with King’s College London and is being led by Dr James Rucker, will recruit up to 42 participants in six cohorts of seven volunteers on increasing doses of 5-MeO-DMT. Blinded data from the study will be used to inform the planned Phase 2 study dose and design 2022 for investigating the use of 5-MeO-DMT in treatment resistant depression (TRD) and other neuropsychiatric indications.
Clinician scientist and principal investigator of the study, from the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, Rucker, commented: “We are pleased to be working with Beckley Psytech and to have initiated this study to evaluate the safety and tolerability of 5-MeO-DMT. TRD is a challenging condition to treat, and it is exciting to be exploring new treatment options that could have a positive impact on patients’ lives in the future.”
CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “The start of this Phase 1 study is hugely exciting for Beckley Psytech and for our continued collaboration with Dr James Rucker and his team at King’s College London.
“This trial will provide invaluable information about our novel intranasal formulation of 5-MeO-DMT, and we are looking forward to the readout in 2022. Following this trial, we intend to initiate a Phase 2 study in TRD, a condition with a significant unmet medical need. This is another key milestone achieved on our path to deliver on our clinical pipeline.”
The trial will also look to characterise the psychedelic experience of the subjects, with interviews carried out by a specialist.
