CompletedPhase 1DMT
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
Sponsored by Usona Institute
NCT ID
NCT05698095
Target Enrollment
54 participants
Start Date
2022-12-27
Est. Completion
2023-09-07
About This Study
The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.
Conditions Studied
Interventions
- •5-methoxy-N,N-dimethyltryptamine succinate salt
- •Placebo
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: * Healthy adult male or female. * Aged at least 18 years but not older than 65 years, inclusive. * Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive. Exclusion Criteria: * History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee). * Participants who, in the opinion of the investigator (or designee), should not participate in this study. * Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.
Study Locations (1)
Altasciences Clinical Kansas, Inc
Overland Park, Kansas, United States