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TP-05 for Tick Prevention in Healthy Subjects
Study Summary
This trialtests if a drug can kill ticks after they've attached to human skin, to see if it's safe and works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 59 years old.You do not smoke or used to smoke cigarettes.I have a serious health condition affecting my heart, lungs, blood, nerves, mental health, hormones, immune system, or skin.Your weight is within a healthy range for your height, not too little or too much.Your body mass index (BMI) falls between 18 and 32, which means you have a healthy weight for your height.I am between 18 and 59 years old.I have a long-term infectious disease.I haven't taken any experimental drugs recently.I have had cancer before, but it was not skin cancer that was treated.I am able to understand and sign the consent form.I am not pregnant, as confirmed by a blood test.I have not taken lotilaner in the last 6 months.I have not received a live vaccine in the last 4 weeks and do not need one during the study.I am currently breastfeeding.I am willing and able to follow all study rules and attend all appointments.I am not on maintenance therapy for any condition and do not have a history of drug or alcohol abuse.I am able to understand and sign the consent form.I have not had any serious illnesses in the last 28 days.I have not taken St. John's wort in the last 28 days.I do not have or have had serious stomach, liver, kidney diseases, or surgeries affecting medication absorption.I haven't taken any drugs except for birth control, HRT, or acetaminophen recently.You must not be a current smoker or someone who has recently quit smoking.
- Group 1: Low Dose of TP-05 (lotilaner)
- Group 2: High Dose of TP-05 (lotilaner)
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who would benefit from partaking in this clinical research?
"To take part in this trial, prospective patients should have healthy subjects (hs) and be aged between 18-59. This study seeks a total of 30 participants."
Is the minimal age requirement for this experiment 18 years or older?
"This medical trial is seeking out those aged 18 and under 59 to participate."
Is the Low Dose of TP-05 (lotilaner) been given regulatory clearance by the FDA?
"Due to the fact that this is a Phase 2 trial, and thus there is preliminary data attesting to its safety but no information regarding efficacy, Low Dose of TP-05 (lotilaner) was awarded a rating of 2."
Could prospective participants still join this experiment?
"Yes, records posted on clinicaltrials.gov demonstrate that this medical trial is actively recruiting applicants. The investigation was first announced on December 12th 2022 and last revised on January 5th 2023; the team behind the research needs 30 participants to be recruited from 1 site."
How many participants can take part in this experiment?
"Affirmative, clinicaltrials.gov indicates that this medical trial is actively seeking participants. It was initially posted on December 12th 2022 and recently edited on January 5th 2023; 30 candidates are being recruited from one site."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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