Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscular (IM) in varying doses from placebo to 16mg. Half of the cohorts (each with 5 getting 5-MeO, 1 placebo) will receive multiples doses (e.g. 2.5mg followed 3 hours later by 4.5mg). The trial will provide valuable data on the pharmacokinetics and safety of 5-MeO-DMT in humans.

Topic Healthy Subjects Safety
Compound 5-MeO-DMT
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 27 December 2022
End date 07 September 2023
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 54
Sex All
Age 18- 65
Therapy No

Trial Details

This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.

NCT Number NCT05698095

Sponsors & Collaborators

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

Data attribution

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