Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects

Beckley Psytech

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics in Healthy Adults

Treatments: Drug: 5-MeO-DMT; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05032833

BPL-5MEO-101

Details and patient eligibility

About

The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects

Enrollment: 36 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

* Medically healthy based on medical records and study specific assessments

Exclusion criteria

* Presence or history of severe adverse reaction to any drug or drug excipient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

5-MeO-DMT arm

Experimental group

Treatment:

Drug: 5-MeO-DMT

Placebo arm

Placebo Comparator group

Treatment:

Other: Placebo