Evaluation of the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers

NCT04674709 | Unknown Phase 1 FDA Drug

• 1 other identifier: AH-O4X-11-2020-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Flu-like Symptoms

Keywords

Flu-like symptoms; Avila Herbals; Phoenix Biotechnology

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events, serious event, and any related reactions as assessed by CTCAE v5.0.

  1-7 days

• proportion of subjects undergoing DLT events

  Safety evaluation

  1-7 days

Secondary Outcomes (4)

• pharmacokinetic parameters - AreaUnderCUrve (AUCt) [Time Frame: 24 hours]

  0-24 hours

• half-life (t1/2)

  0-24 hours

• maximum and minimum plasma concentration

  0-24 hours

• total body clearance (Cltot)

  0-24 hours

Study Arms (2)

Safety of Oleander 4X HPUS

PLACEBO COMPARATOR

: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).

Drug: Oleander 4X - single; Drug: Oleander 4X - double; Drug: Oleander 4X - quadruple; Drug: Placebo

Pharmacokinetics evaluation of Oleander 4X HPUS

EXPERIMENTAL

To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.

Drug: Oleander 4X - single; Drug: Oleander 4X - double; Drug: Oleander 4X - quadruple; Drug: Placebo

Interventions

Oleander 4X - single DRUG

Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.

Pharmacokinetics evaluation of Oleander 4X HPUS; Safety of Oleander 4X HPUS

Oleander 4X - double DRUG

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.

Pharmacokinetics evaluation of Oleander 4X HPUS; Safety of Oleander 4X HPUS

Oleander 4X - quadruple DRUG

Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.

Pharmacokinetics evaluation of Oleander 4X HPUS; Safety of Oleander 4X HPUS

Placebo DRUG

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; Safety of Oleander 4X HPUS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avila Herbals: lead

Study Sites (1)

Dr. William Ball offices

Roanoke, Virginia, 24017, United States

RECRUITING

Study Officials

• Theresa G Obiso, PhD

  Avila Herbals

  STUDY DIRECTOR

Central Study Contacts

Richard J Obiso, PhD

CONTACT

800-936-0197; rik@obisoco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple: Triple (Participant, Care provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled Phase I study that will investigate the safety and efficacy of OLEANDER 4X HPUS in Healthy Volunteers.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 19, 2020
• Study Start: November 24, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)