NCT04674709

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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Avila Herbals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Detailed description

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).

Conditions

• Flu-like Symptoms

Interventions

Type	Name	Description
DRUG	Oleander 4X - single	Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
DRUG	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.
DRUG	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.
DRUG	Placebo	The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days

Timeline

• Start date: 2020-11-24
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2020-12-19
• Last updated: 2020-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study