Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers (NCT05698095) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
United States54 participantsStarted 2022-12-27
Plain-language 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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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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.
What they're measuring
1
Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0