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5-MeO-DMT

Phase 1

Pharmacokinetics in Healthy Adults | Small molecule | Other |AtaiBeckley Inc.|Last Updated: Oct 12, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

5-MeO-DMT · 1 trial · 1 indication

Phase 1 1
NCT05032833Single Ascending Dose Study With 5-MeO-DMT in Healthy SubjectsPharmacokinetics in Healthy Adults
COMPLETED36 Analytics
PHASE1COMPLETED
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Pharmacokinetics in Healthy AdultsUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5-MeO-DMT armEXPERIMENTAL -
Placebo armPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
5-MeO-DMTDRUGA single dose of 5-MeO-DMT will be administered intranasally
PlaceboOTHERA single dose of placebo will be administered intranasally
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Eligibility Criteria

Age Range25 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:United Kingdom
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Frequently asked questions about 5-MeO-DMT

What is 5-MeO-DMT used for?

5-MeO-DMT is an investigational small molecule being studied for pharmacokinetics in healthy adults. It is currently in Phase 1 clinical development, with a completed single ascending dose study in healthy volunteers. The drug is not approved and remains under investigation.

Who makes 5-MeO-DMT?

5-MeO-DMT is being developed by AtaiBeckley Inc., a biopharmaceutical company. The company's stock is traded under the ticker ATAI. The drug is currently in Phase 1 clinical development for pharmacokinetics in healthy adults.

What phase is 5-MeO-DMT in?

5-MeO-DMT is in Phase 1 clinical development. A single ascending dose study in healthy subjects has been completed. The drug is investigational and has not been approved for any use.

What clinical trials is 5-MeO-DMT in?

5-MeO-DMT has one completed Phase 1 trial, NCT05032833, titled 'Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects.' This randomized, double-blind, placebo-controlled study enrolled 36 healthy adults in the United Kingdom.

Is 5-MeO-DMT FDA approved?

5-MeO-DMT is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed trial, NCT05032833, studied its pharmacokinetics in healthy adults, but the drug remains under investigation.