Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
NCT ID: NCT05894902
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2023-10-01
2024-06-30
Brief Summary
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Detailed Description
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This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Level 1: 0.5 mL/kg ("low"; 50% of usual dose) N=4 (2M/2F) Level 2: 1 ml/kg ("medium"; 100% of usual dose) N=4 (2M/2F) Level 3: 2 ml/kg ("high"; 200% of usual dose) N=4 (2M/2F)
TREATMENT
NONE
Study Groups
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Open label Phase I safety & dose finding study: low dose group
4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001
SM-001
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
Open label Phase I safety & dose finding study: medium dose group
4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001
SM-001
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
Open label Phase I safety & dose finding study: high dose group
4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001
SM-001
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
Interventions
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SM-001
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
65 Years
ALL
Yes
Sponsors
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Advanced Integrative Medical Science Institute
OTHER
Responsible Party
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Principal Investigators
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Leanna J Standish, ND PhD
Role: PRINCIPAL_INVESTIGATOR
AIMS Institute
Locations
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AIMS Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SM-001
Identifier Type: -
Identifier Source: org_study_id
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