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Isoxazoline

TP-05 for Tick Prevention in Healthy Subjects

Phase 2
Recruiting
Led By Linden Hu, MD
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1 through day 301
Awards & highlights

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.

Who is the study for?
This trial is for non-smoking or ex-smoking healthy adults aged 18-59 with a BMI of 18-32 kg/m^2. Participants must be in good health, not have significant medical conditions, and agree to use contraception. They should be willing to follow study procedures and not have any history of severe reactions to tick bites or certain chronic diseases.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of TP-05 (lotilaner) at low and high doses compared to a placebo in killing ticks on human skin. It's a Phase 2a, randomized, double-blind trial where participants won't know if they're getting TP-05 or an inactive substance.See study design
What are the potential side effects?
While specific side effects are not listed for TP-05 (lotilaner), common side effects may include irritation at the application site, allergic reactions, or other symptoms that will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 59 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -1 through day 301
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1 through day 301 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically significant changes from Baseline QRS interval
Clinically significant changes from Baseline QTC interval
Clinically significant changes from Baseline chemistry laboratory tests
+5 more
Secondary outcome measures
Evaluate the concentration of lotilaner in whole blood
TP-05 on Tick Mortality

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose of TP-05 (lotilaner)Experimental Treatment1 Intervention
Single Oral Low Dose of TP-05 tablet.
Group II: High Dose of TP-05 (lotilaner)Experimental Treatment1 Intervention
Single Oral High Dose of TP-05 tablet.
Group III: PlaceboPlacebo Group1 Intervention
Single Oral Dose of placebo tablet.

Find a Location

Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,245 Total Patients Enrolled
Jose Trevejo, CMOStudy DirectorTarsus Pharmaceuticals, Inc.
Linden Hu, MDPrincipal InvestigatorTufts University School of Medicine

Media Library

TP-05 (Isoxazoline) Clinical Trial Eligibility Overview. Trial Name: NCT05387083 — Phase 2
Healthy Subjects Research Study Groups: Low Dose of TP-05 (lotilaner), High Dose of TP-05 (lotilaner), Placebo
Healthy Subjects Clinical Trial 2023: TP-05 Highlights & Side Effects. Trial Name: NCT05387083 — Phase 2
TP-05 (Isoxazoline) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387083 — Phase 2
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05387083 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Tufts University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I live in a wooded area and have had tick on me previously. I think it's great that there may be a drug that may help prevent ticks from spreading diseases.
PatientReceived 1 prior treatment
~3 spots leftby Jun 2024