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

NCT07562087 · tracked via the Priya Life Science USA tracker

Sponsor

Tarsus Pharmaceuticals, Inc.

Phase

Phase 2

Started

2026-03-09

Last updated

2026-07-09

Condition(s) studied

Lyme Disease

Investigational drug(s) / intervention(s)

TP-05 (lotilaner) Low DoseTP-05 (lotilaner) High DosePlacebo

TP-05 (lotilaner) Low Dose: TP05 administered orally at the protocol-defined preventative dose.

TP-05 (lotilaner) High Dose: TP05 administered orally at the protocol-defined preventative dose.

Placebo: Matching placebo administered orally according to the same dosing schedule as TP05.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

The Incidence of Treatment Emergent Adverse Events From Baseline — From 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 Tests — From 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 Tests — From 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 Signs — From 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) Measures — 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 pulse rate \[msec\].
Clinically Significant Changes From Baseline QTC Interval — 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 QTC interval
Clinically Significant Changes From Baseline QRS Interval — 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 QRS interval.

Trial sites (19)

Facility	City	Region
Study Site	Pikesville	Maryland
Study Site	Brookline	Massachusetts
Study Site	Fall River	Massachusetts
Study Site	Minneapolis	Minnesota
Study Site	Marlboro	New Jersey
Study Site	Albany	New York
Study Site	Binghamton	New York
Study Site	Buffalo	New York
Study Site	East Syracuse	New York
Study Site	Middletown	New York
Study Site	New York	New York
Study Site	Rochester	New York
Study Site	Erie	Pennsylvania
Study Site	Hatboro	Pennsylvania
Study Site	Philadelphia	Pennsylvania
Study Site	Pittsburgh	Pennsylvania
Study Site	Pottstown	Pennsylvania
Study Site	West Chester	Pennsylvania
Study Site	Warwick	Rhode Island

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07562087 on ClinicalTrials.gov ↗ ← All trials in the USA