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

Phase 1CompletedNCT05032833

Beckley Psytech Limited36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pharmacokinetics in Healthy Adults

Interventions

5-MeO-DMTDRUG

A single dose of 5-MeO-DMT will be administered intranasally

PlaceboOTHER

A single dose of placebo will be administered intranasally

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

King's College London

London, United Kingdom

Outcomes

Primary Outcomes

Percentage of subjects with treatment emergent AEs (TEAES)

Time frame: From screening through to the follow up visit, up to 65 days

Secondary Outcomes

Peak plasma concentration (Cmax)

Time frame: Day 1 (dosing day) and Day 2

Time to reach Cmax (tmax)

Time frame: Day 1 (dosing day) and Day 2

Area under the plasma concentration- time curve

Time frame: Day 1 (dosing day) and Day 2

Data from ClinicalTrials.gov

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