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CompletedPhase 1

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

NCT05698095 · Usona Institute

Closed to entry
Status
Not accepting participants
Phase 1
Phase
54
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0

    Measured over Up to 30 Days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Altasciences Clinical Kansas, IncOverland ParkKansasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05698095 on ClinicalTrials.gov →

Last updated in the registry 2023-11-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits