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

Usona Institute

Status and phase: Completed; Phase 1

Conditions: Tolerability; Safety; Pharmacokinetics

Treatments: Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05698095

MEO101

Details and patient eligibility

About

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.

Full description

This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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54 participants in 9 patient groups

Cohort 1 - 0.5 mg single-dose

Experimental group

Description:

A single 0.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 2 - 2.5 mg single-dose

Experimental group

Description:

A single 2.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 3 - 4.5 mg single-dose

Experimental group

Description:

A single 4.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 4 - 7 mg single-dose

Experimental group

Description:

A single 7 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 5 - 10 mg single-dose

Experimental group

Description:

A single 10 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 6 - 13 mg single-dose

Experimental group

Description:

A single 5-MeO-DMT 13 mg or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 7 - multiple-dose, 3 hour interval

Experimental group

Description:

Administration of up to two 5-MeO-DMT (2.5 mg followed by 4.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 8 - multiple-dose, 3 hour interval

Experimental group

Description:

Administration of up to two 5-MeO-DMT (2.5 mg followed by 7 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt

Cohort 9 - multiple-dose, 3 hour interval

Experimental group

Description:

Administration of up to two 5-MeO-DMT (2.5 mg followed by 10.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).

Treatment:

Drug: Placebo

Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt