Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers
详细描述
The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: SM-001 (Drug)
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
干预措施: SM-001 (Drug)
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
干预措施: SM-001 (Drug)
结局指标
主要结局
Primary Objective
时间窗: 1-28 days
To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Percentage of participants with at least one safety event \[Time Frame: Baseline up to Day 28 \] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.
次要结局
- Bioavailability of SM-001(Day 1-2)
- Short-term psychological impact(24 hours after single drug session)
- Effects of a single dose of SM-001 on blood cortisol blood levels(Day 1 - 28)
- Longer-term psychological impact(Day 7 after a single drug session)
- Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor(Day 1-28)