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

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.

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.