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NCT07562087

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

Active, Not Recruiting
PHASE2Ages 18–70InterventionalTreatment
Tarsus Pharmaceuticals, Inc.
~722 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:TP-05 (lotilaner) Low DoseTP-05 (lotilaner) High DosePlacebo

At a glance

Recruiting sites
0 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Incidence of Treatment Emergent Adverse Events From Baseline
Measured over From day 1 through the end of study follow-up, an average of 15 months.
+7 more outcomes measured

Conditions

Lyme Disease

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NCT07562087

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Study Site

    Pikesville, Marylandno site contact published

  • Study Site

    Brookline, Massachusettsno site contact published

  • Study Site

    Fall River, Massachusettsno site contact published

  • Study Site

    Minneapolis, Minnesotano site contact published

  • Study Site

    Marlboro, New Jerseyno site contact published

  • Study Site

    Albany, New Yorkno site contact published

  • Study Site

    Binghamton, New Yorkno site contact published

  • Study Site

    Buffalo, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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 this trial measures

  • The Incidence of Treatment Emergent Adverse Events From BaselineFrom day 1 through the end of study follow-up, an average of 15 months.

    Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.

  • Clinically Significant Changes From Baseline Chemistry Laboratory TestsFrom day 1 through the end of study follow up, an average of 15 months.

    Number of participants with clinically significant changes in clinical laboratory tests

  • Clinically Significant Changes From Baseline Hematology Laboratory TestsFrom day 1 through the end of study follow up, an average of 15 months.

    Number of participants with clinically significant changes in clinical laboratory tests.

  • Clinically Significant Changes From Baseline Vital SignsFrom day 1 through the end of study follow up, an average of 15 months.

    Number of participants with clinically significant changes in vital signs.

  • Clinically Significant Changes From Baseline Electrocardiograms (ECGs)From day 1 through the end of study follow up, an average of 15 months.

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].

  • Clinically Significant Changes From Baseline Electrocardiograms (ECGs) MeasuresFrom day 1 through the end of study follow up, an average of 15 months.

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].

  • Clinically Significant Changes From Baseline QTC IntervalFrom day 1 through the end of study follow up, an average of 15 months.

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval

  • Clinically Significant Changes From Baseline QRS IntervalFrom day 1 through the end of study follow up, an average of 15 months.

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.