Evaluation of the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
NCT ID: NCT04674709
Last Updated: 2020-12-21
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
75 participants
INTERVENTIONAL
2020-11-24
2021-01-15
Brief Summary
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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).
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Safety of Oleander 4X HPUS
: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).
Oleander 4X - single
Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
Oleander 4X - double
Cohort 2 receive 2 doses of either active drug or placebo 4 times per day in a 24-hour period for a period of seven days.
Oleander 4X - quadruple
Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.
Placebo
The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days
Pharmacokinetics evaluation of Oleander 4X HPUS
To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.
Oleander 4X - single
Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
Oleander 4X - double
Cohort 2 receive 2 doses of either active drug or placebo 4 times per day in a 24-hour period for a period of seven days.
Oleander 4X - quadruple
Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.
Placebo
The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days
Interventions
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Oleander 4X - single
Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
Oleander 4X - double
Cohort 2 receive 2 doses of either active drug or placebo 4 times per day in a 24-hour period for a period of seven days.
Oleander 4X - quadruple
Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.
Placebo
The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Avila Herbals
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa G Obiso, PhD
Role: STUDY_DIRECTOR
Avila Herbals
Locations
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Dr. William Ball offices
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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William Ball, MD
Role: primary
Other Identifiers
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AH-O4X-11-2020-01
Identifier Type: -
Identifier Source: org_study_id