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Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

Open-label, Phase I dose-ranging safety study (n=12) in healthy adults testing single oral doses of SM-001 (0.5, 1.0, 2.0 mL/kg) to assess safety and plasma biomarkers.

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Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This Phase I open-label study consecutively assigns 12 healthy adult volunteers to one of three single-dose SM-001 groups (0.5, 1.0, 2.0 mL/kg) to evaluate safety, tolerability and systemic exposure.

Plasma levels of DMT, harmine, tetrahydroharmine and harmaline will be measured pre-dose and at 1, 2, 4, 8 and 24 hours post-dose; final in-person follow-up on Day 28.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Low dose

experimental

SM-001 0.5 mL/kg oral single dose; n=4 (2M/2F).

Interventions

  • Ayahuasca0.5 ml/kg
    via Oral• single dose• 1 doses total

    SM-001 decoction of Banisteriopsis caapi and Psychotria viridis; 0.5 mL/kg; n=4 (2M/2F).

Medium dose

experimental

SM-001 1.0 mL/kg oral single dose; n=4 (2M/2F).

Interventions

  • Ayahuasca1 ml/kg
    via Oral• single dose• 1 doses total

    SM-001 decoction; 1.0 mL/kg; n=4 (2M/2F).

High dose

experimental

SM-001 2.0 mL/kg oral single dose; n=4 (2M/2F).

Interventions

  • Ayahuasca2 ml/kg
    via Oral• single dose• 1 doses total

    SM-001 decoction; 2.0 mL/kg; n=4 (2M/2F).

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Healthy adults: men and women ages 25-65 years of age
  • Previous experience with a psychedelic drug
  • Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate
  • Normal blood pressure (for age) in the absence of antihypertensive drugs
  • Normal complete blood count and differential, platelets, coagulation (PT/PTT)
  • Liver function tests ≤ 1.5X upper limits of normal
  • Renal function (BUN, serum Creatinine) - within normal limits
  • Able to understand and willing to comply with Study Protocol requirements.
  • Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0
  • No use of recreational drugs for at least 14 days prior to Study Day 0.
  • Women who are not pregnant or lactating.

Exclusion Criteria

  • Exclusion Criteria:
  • Body Mass Index > 30 or < 20
  • Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters.
  • History of seizures
  • History of drug or alcohol abuse
  • History of psychiatric disorder or history of significant trauma, as defined by DSM- V.
  • Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort)
  • Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.

Study Details

Study Team

Sponsors & Collaborators

Locations

AIMS Institute — Seattle, Washington, United States