RecruitingPhase 2NCT07562087

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TP-05 in Healthy Participants at High Risk of Tick Exposure

Sponsor

Tarsus Pharmaceuticals, Inc.

Enrollment

700 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Lyme Disease

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called TP-05 (lotilaner) High Dose, and others for people with lyme disease. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTP-05 (lotilaner) Low Dose

TP05 administered orally at the protocol-defined preventative dose.

DRUGTP-05 (lotilaner) High Dose

TP05 administered orally at the protocol-defined preventative dose.

DRUGPlacebo

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

Locations(19)

Study Site

Pikesville, Maryland, United States

Study Site

Brookline, Massachusetts, United States

Study Site

Fall River, Massachusetts, United States

Study Site

Minneapolis, Minnesota, United States

Study Site

Marlboro, New Jersey, United States

Study Site

Albany, New York, United States

Study Site

Binghamton, New York, United States

Study Site

Buffalo, New York, United States

Study Site

East Syracuse, New York, United States

Study Site

Middletown, New York, United States

Study Site

New York, New York, United States

Study Site

Rochester, New York, United States

Study Site

Erie, Pennsylvania, United States

Study Site

Hatboro, Pennsylvania, United States

Study Site

Philadelphia, Pennsylvania, United States

Study Site

Pittsburgh, Pennsylvania, United States

Study Site

Pottstown, Pennsylvania, United States

Study Site

West Chester, Pennsylvania, United States

Study Site

Warwick, Rhode Island, United States

View Full Details on ClinicalTrials.gov

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NCT07562087

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