Clinical
Trials

Phase IIb BPL-003 study in patients with Treatment Resistant Depression

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5-MeO-DMT

We completed the placebo-controlled phase of our single ascending dose study of BPL-003 (our intranasal formulation of 5-MeO-DMT) in healthy volunteers in November 2022 and we are now conducting a Phase IIb study of BPL-003 in patients with Treatment Resistant Depression (TRD). The randomised, dose-finding study (NCT05870540) is taking place at 40 sites across Australia, Germany, Poland, Spain, the United Kingdom and the United States, and will evaluate the effects of a medium or high dose of BPL-003 against an active placebo in patients with moderate to severe TRD, alongside psychological support.

Phase IIb study details

Phase IIa BPL-003 monotherapy study in patients with Treatment Resistant Depression

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5-MeO-DMT

We completed the placebo-controlled phase of our single ascending dose study of BPL-003 (our intranasal formulation of 5-MeO-DMT) in healthy volunteers in November 2022 and we are now conducting a Phase IIa open-label study of BPL-003 in patients with Treatment Resistant Depression (TRD). The study (NCT05660642) is taking place at King’s College London and Hammersmith Medicines Research (HMR) in London, and will involve patients with moderate to severe symptoms who have not shown an adequate response to prior standard antidepressant medication. The study will evaluate the safety and efficacy of a single dose of BPL-003 alongside psychological support.

Phase IIa study details

Phase IIa BPL-003 study in patients with Alcohol Use Disorder

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5-MeO-DMT

We completed the placebo-controlled phase of our single ascending dose study of BPL-003 (our intranasal formulation of 5-MeO-DMT) in healthy volunteers in November 2022 and we are now conducting a Phase IIa open-label study of BPL-003 in patients with Alcohol Use Disorder (AUD). The study (NCT05674929) is taking place at King’s College in London, and will investigate the safety and efficacy of a single dose of BPL-003 given alongside an abstinence-oriented cognitive behavioural psychological intervention in patients with AUD.

Phase IIa study details
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​​Phase I ELE -101 Study in Healthy Volunteers

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Psilocin

We are conducting a Phase I study of ELE -101 in healthy volunteers in Manchester and Liverpool. This is a Phase I, double-blind, placebo-controlled, randomised single ascending dose study to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective drug intensity (SDI) of intravenous (IV) doses of ELE-101 in healthy male and female adult participants.

Phase I study details
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Investigator Initiated Studies

We are committed to understanding the therapeutic potential of psychedelic drugs and support rigorous investigator-initiated research advancing psychedelic science.

We work in collaboration with select academic institutions and researchers.

For general information about our ongoing research activities, please use the contact form on our website or email us on medinfo@beckleypsytech.com

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