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 range18 Years – 70 Years

SexALL

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

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.

Clinically Significant Changes From Baseline QTC Interval

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 range18 Years – 70 Years

SexALL

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.

Clinically Significant Changes From Baseline QTC Interval

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