RecruitingPhase 2

A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure

United States700 participantsStarted 2026-03-09

Plain-language summary

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Overtly healthy adult participants aged 18 to 70 years * Able to provide written informed consent * Willing and able to comply with study procedures * At high risk of exposure to ticks * Contraceptive use by men and women consistent with local regulations Exclusion Criteria: * Prior exposure to TP05 or any isooxazoline in the last 12 months * Known hypersensitivity to TP05 or related compounds * Clinically significant medical conditions that may interfere with study participation * Use of investigational products within 30 days prior to screening. * Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis * Receiving long-term antibiotic therapy * Received active or passive immunization within 4 weeks prior to Day * Pregnant or breastfeeding individuals

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Incidence of Treatment Emergent Adverse Events From Baseline

Timeframe: From day 1 through the end of study follow-up, an average of 15 months.

Clinically Significant Changes From Baseline Chemistry Laboratory Tests

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Hematology Laboratory Tests

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Vital Signs

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Electrocardiograms (ECGs)

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Trial details

NCT IDNCT07562087

SponsorTarsus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Study Director

949-418-1801

View on ClinicalTrials.gov More Lyme Disease trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Incidence of Treatment Emergent Adverse Events From Baseline

Timeframe: From day 1 through the end of study follow-up, an average of 15 months.

Clinically Significant Changes From Baseline Chemistry Laboratory Tests

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Hematology Laboratory Tests

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Vital Signs

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Electrocardiograms (ECGs)

Timeframe: From day 1 through the end of study follow up, an average of 15 months.

Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures

Timeframe: From day 1 through the end of study follow up, an average of 15 months.