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

A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05032833

Enrollment

Registered

2021-09-02

Start date

2021-09-22

Completion date

2022-07-07

Last updated

2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics in Healthy Adults

Brief summary

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

Interventions

DRUG5-MeO-DMT

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

OTHERPlacebo

A single dose of placebo will be administered intranasally

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with treatment emergent AEs (TEAES)	From screening through to the follow up visit, up to 65 days

Secondary

Measure	Time frame
Peak plasma concentration (Cmax)	Day 1 (dosing day) and Day 2
Time to reach Cmax (tmax)	Day 1 (dosing day) and Day 2
Area under the plasma concentration- time curve	Day 1 (dosing day) and Day 2

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026