TP-05 for Tick Prevention in Healthy Subjects

Overseen By Linden Hu, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Tarsus Pharmaceuticals, Inc.

Must not be taking: St. John's wort

Disqualifiers: Pregnancy, Cardiovascular disease, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 303

Duration: 60 days

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking most non-prescription or prescription drugs, except for hormonal contraceptives, hormone replacement therapy, and acetaminophen, at least 7 days before starting the study. If the drug is a potential enzyme inducer, you need to stop 14 days before. Please check with the study team for specific guidance on your medications.

What is the purpose of this trial?

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.

Research Team

Yoav Golan

Principal Investigator

Tufts Medical Center

Linden Hu, MD

Principal Investigator

Tufts University School of Medicine

Kavita Dhamdhere, MD, PhD

Principal Investigator

Tarsus Pharmaceuticals, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Participants must be non- or ex-smokers

Participants must be overtly healthy as determined by medical evaluation, with no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

I have a serious health condition affecting my heart, lungs, blood, nerves, mental health, hormones, immune system, or skin.

History of significant hypersensitivity to lotilaner or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs

Presence of clinically significant ECG abnormalities at Screening, as defined by the Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either low dose or high dose of TP-05 or placebo, with tick placement and mortality assessment

60 days

Multiple visits (in-person) on Day -1, Day 1, Day 2, Day 30, and Day 31

Follow-up

Participants are monitored for safety and effectiveness after treatment, including additional safety and PK visits

241 days

Multiple visits (in-person) through Day 301

Treatment Details

Interventions

• TP-05

Trial Overview 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.

Participant Groups

Group I: Low Dose of TP-05 (lotilaner) Experimental Treatment 1 Intervention

Single Oral Low Dose of TP-05 tablet.

Group II: High Dose of TP-05 (lotilaner) Experimental Treatment 1 Intervention

Single Oral High Dose of TP-05 tablet.

Group III: Placebo Placebo Group 1 Intervention

Single Oral Dose of placebo tablet.

Who Is Running the Clinical Trial?

Tarsus Pharmaceuticals, Inc.

Lead Sponsor

Trials

10

Recruited

1,300+