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

SM-001

Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers

2023-10-01

2024-04-30

2024-06-30

Not yet recruiting

Early phase I

12

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 (None can apply): * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Subjects will be consecutively accrued to one of three study groups, starting at the lowest dose, Level 1 ("low" dose), and proceeding to the next higher dose level. Each subject will receive one dose of the Study Drug orally at the Clinical Study Site, according to their assigned dose Level. Dose levels vary by volume:\n\nLevel 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)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-07-07