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

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 27, 2022

Primary Completion Date

September 7, 2023

Study Completion Date

September 7, 2023

Conditions
PharmacokineticsSafetyTolerability
Interventions
DRUG

5-methoxy-N,N-dimethyltryptamine succinate salt

The 5-MeO-DMT drug product is comprised of the appropriate concentration of 5-MeO-DMT succinate salt drug substance in solution with 0.9% sodium chloride injection solution (USP) in a 5 mL glass vial, and is administered intramuscularly.

DRUG

Placebo

The placebo is commercially available 0.9% sodium chloride solution (USP) for injection. The placebo is provided by the pharmacy in single-use sterile syringes of the appropriate dose.

Trial Locations (1)

66212

Altasciences Clinical Kansas, Inc, Overland Park

All Listed Sponsors
lead

Usona Institute

OTHER