A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events, serious event, and any related reactions as assessed by CTCAE v5.0.
研究概览
简要总结
The homeopathic medicine, Oleander 4X HPUS is indicated for temporary relief of symptoms associated with flu, such as muscle or body aches, headaches, chills and fever, cough, and congestion. The primary purpose of this study is to assess the safety of Oleander 4X HPUS in health male and female subjects compared to a placebo. This is a randomized, double blind, placebo-controlled Phase I Proof of Concept clinical trial to evaluate the safety and efficacy of OLEANDER 4X HPUS in Healthy Volunteers. Briefly, 45 Healthy volunteers who meet the eligibility criteria and agree to participation in the study will be placed on 1.0 mL of OLEANDER 4X HPUS, four-to-twelve times per day for seven days. For the pharmacokinetics study (cohorts 4-6), participants will take OLEANDER 4X HPUS at a prescribed dose one time.
The aim of the present study is to evaluate the safety of OLEANDER 4X HPUS. This real-world cohort provides a unique opportunity to study this medicine. This protocol outlines a study involving Healthy volunteers. Up to 45 volunteers will be recruited in specific health systems in the USA.
Second ARM, sub-study: As a second arm of this study, a random double blind, placebo-controlled pharmacokinetics study in healthy volunteers. Briefly, 15 healthy volunteers who meet the same eligibility criteria and agree to participation in the study will be placed on one, two, or 4 doses (1 mL per dose) of OLEANDER 4X HPUS one time.
This is effectively three ascending doses in 4 subjects on OLEANDER 4X HPUS, compared to the placebo (1 subject).
详细描述
The aim of the present study is to evaluate the safety of OLEANDER 4X HPUS. This protocol outlines a study involving Healthy volunteers. Up to 45 volunteers will be recruited in the USA.
Second ARM, sub-study: As a second arm of this study, a random double blind, placebo-controlled pharmacokinetics study in healthy volunteers. Briefly, 15 healthy volunteers who meet the same eligibility criteria and agree to participation in the study will be placed on one, two, or 4 doses (1 mL per dose) of OLEANDER 4X HPUS one time.
This is effectively three ascending doses in 4 subjects on OLEANDER 4X HPUS, compared to the placebo (1 subject).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple: Triple (Participant, Care provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers.
- •Subjects with no symptoms of respiratory illness such as fever, rhinorrhea, mild cough, sore throat, headache, fatigue, muscle pain, and malaise but with no shortness of breath.
- •Male or non-pregnant female adult > 18 to 65 years of age at time of enrollment to include all races and ethnic minorities.
- •Agree to the collection of blood specimens (for the pharmacokinetics study).
- •Willingness of study participant to provide informed consent and accept randomization to any assigned treatment arm.
- •Must agree not to enroll in another study of an investigational agent prior to Day 28 of study, unless hospitalized.
排除标准
- •Signs of any respiratory distress or pulmonary infection defined as the need for non-invasive or invasive mechanical ventilator support, ECMO or shock requiring vasopressor support.
- •Subjects with risk factors for severe disease (e.g. hypertension, diabetes, pulmonary, cardiovascular, renal, hepatic, neurologic disease or immune compromise, obesity, and pregnancy).
- •Any previous history of clinically significant cardiovascular disease, including ventricular arrhythmias.
- •Current use of cardiac glycosides or a known allergic reaction to cardiac glycosides or compounds of similar chemical or biologic composition.
- •Any risk factors that can lead to severe COVID-19 including uncontrolled diabetes, hypertension, and systemic diseases including hepatic disease and renal insufficiency.
- •Pregnancy or breastfeeding.
- •Participation in any other clinical trial of an experimental treatment for COVID-19.
研究组 & 干预措施
Safety of Oleander 4X HPUS
: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).
干预措施: Oleander 4X - single (Drug)
Safety of Oleander 4X HPUS
: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).
干预措施: Oleander 4X - double (Drug)
Safety of Oleander 4X HPUS
: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).
干预措施: Oleander 4X - quadruple (Drug)
Safety of Oleander 4X HPUS
: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).
干预措施: Placebo (Drug)
Pharmacokinetics evaluation of Oleander 4X HPUS
To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.
干预措施: Oleander 4X - single (Drug)
Pharmacokinetics evaluation of Oleander 4X HPUS
To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.
干预措施: Oleander 4X - double (Drug)
Pharmacokinetics evaluation of Oleander 4X HPUS
To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.
干预措施: Oleander 4X - quadruple (Drug)
Pharmacokinetics evaluation of Oleander 4X HPUS
To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events, serious event, and any related reactions as assessed by CTCAE v5.0.
时间窗: 1-7 days
proportion of subjects undergoing DLT events
时间窗: 1-7 days
Safety evaluation
次要结局
- half-life (t1/2)(0-24 hours)
- maximum and minimum plasma concentration(0-24 hours)
- total body clearance (Cltot)(0-24 hours)
- pharmacokinetic parameters - AreaUnderCUrve (AUCt) [Time Frame: 24 hours](0-24 hours)