What is the mechanism of action of this treatment?

TP-05 (lotilaner) is an ectoparasiticide that works by interfering with the nervous system of ticks, leading to their death. Similar treatments often target the nervous systems of parasites, causing paralysis and death, which prevents the transmission of tick-borne diseases. For healthy subjects, these treatments are crucial as they provide a preventive measure against infections such as Lyme disease, ensuring that the subjects remain free from the potential complications associated with tick bites.

What side effects are associated with this type of intervention?

Common treatments for ectoparasitic infestations similar to TP-05 (lotilaner) include sarolaner (Simparica™) and ivermectin. Sarolaner has been shown to be highly effective against fleas and ticks in dogs with no treatment-related adverse events reported. Ivermectin, used for onchocerciasis in humans, has a higher incidence of adverse reactions initially, including joint pain, which decreases with subsequent treatments. Overall, these treatments are generally well-tolerated, but initial side effects can occur.

What prior FDA approvals exist?

The FDA has approved several ectoparasiticides for the treatment of infestations in both humans and animals. For example, sarolaner (Simparica™) is an isoxazoline class drug approved for use in dogs to treat flea and tick infestations by interfering with the nervous system of these parasites. While specific FDA approvals for human use of similar drugs are less common, the principles of targeting the nervous system of ectoparasites remain consistent across treatments.

What other types of research exist?

Promising alternatives to TP-05 (lotilaner) for ectoparasite treatment in 2024 include: afoxolaner (NexGard®), fipronil plus permethrin (Frontline® Tri-Act), and collars impregnated with flumethrin and propoxur. These treatments have shown efficacy in killing ticks in various studies.

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Isoxazoline

TP-05 for Tick Prevention in Healthy Subjects

Phase 2

Waitlist Available

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

Must not have

Known history of chronic infectious disease

Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -1 through day 301

Summary

This trial tests TP-05, a medication aimed at killing ticks that attach to human skin. Participants will have ticks placed on their skin and will receive either TP-05 or another treatment. The study will measure how well TP-05 kills the ticks by affecting their nervous system.

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.

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.

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

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I am between 18 and 59 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a long-term infectious disease.

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I haven't taken any experimental drugs recently.

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I am not pregnant, as confirmed by a blood test.

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I have not taken lotilaner in the last 6 months.

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I have not received a live vaccine in the last 4 weeks and do not need one during the study.

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I am currently breastfeeding.

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I am not on maintenance therapy for any condition and do not have a history of drug or alcohol abuse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -1 through day 301

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Dose TP-05

2022

Completed Phase 2

~30

High Dose TP-05

2022

Completed Phase 2

~30

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TP-05 (lotilaner) is an ectoparasiticide that works by interfering with the nervous system of ticks, leading to their death. Similar treatments often target the nervous systems of parasites, causing paralysis and death, which prevents the transmission of tick-borne diseases. For healthy subjects, these treatments are crucial as they provide a preventive measure against infections such as Lyme disease, ensuring that the subjects remain free from the potential complications associated with tick bites.

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