Clinical TrialHealthy Volunteers5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMTPlaceboCompleted

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

This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscularly in varying doses (single 0.5–13 mg and multiple-dose combinations) in healthy adults to assess pharmacokinetics, safety, and tolerability.

Target Enrollment
54 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Phase I, randomized, triple-blind, placebo-controlled, sequential-group study in 54 healthy adults assessing single-ascending and multiple-ascending IM doses of 5-MeO-DMT (single doses 0.5–13 mg; multiple-dose schedules include 2.5 mg followed by 4.5, 7, or 10.5 mg with a 3-hour interval).

Primary objective is characterisation of pharmacokinetics, safety, and tolerability; secondary assessments include adverse events, vitals, ECGs, and laboratory evaluations across acute and follow-up visits.

Randomization is 5:1 active to placebo per cohort with separate single- and multiple-dose parts and sequential dose escalation based on safety review.

Study Arms & Interventions

5-MeO-DMT IM

experimental

Intramuscular 5-MeO-DMT single-ascending (0.5–13 mg) and multiple-ascending dose cohorts (2.5 mg followed by 4.5/7/10.5 mg, 3 h apart). Randomized 5:1 active:placebo per cohort.

Interventions

  • 5-MeO-DMT0.5 mg
    via IM• single dose

    Cohort 1 single-dose 0.5 mg.

  • 5-MeO-DMT2.5 mg
    via IM• single dose

    Cohort 2 single-dose 2.5 mg.

  • 5-MeO-DMT4.5 mg
    via IM• single dose

    Cohort 3 single-dose 4.5 mg.

  • 5-MeO-DMT7 mg
    via IM• single dose

    Cohort 4 single-dose 7 mg.

  • 5-MeO-DMT10 mg
    via IM• single dose

    Cohort 5 single-dose 10 mg.

  • 5-MeO-DMT13 mg
    via IM• single dose

    Cohort 6 single-dose 13 mg.

  • 5-MeO-DMT2.5 - 4.5 mg
    via IM• two doses• 2 doses total

    2.5 mg then 4.5 mg, 3 h apart (multiple-dose cohorts).

  • 5-MeO-DMT2.5 - 7 mg
    via IM• two doses• 2 doses total

    2.5 mg then 7 mg, 3 h apart.

  • 5-MeO-DMT2.5 - 10.5 mg
    via IM• two doses• 2 doses total

    2.5 mg then 10.5 mg, 3 h apart.

Placebo IM

inactive

Saline placebo administered IM, volume matched; randomized 1 per 6 in each cohort.

Interventions

  • Placebo
    via IM• single dose

    0.9% sodium chloride injection; administered single or as matched two-dose schedule per cohort.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

Locations

Altasciences Clinical Kansas, Inc — Overland Park, Kansas, United States

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