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RECRUITING
NCT07562087
PHASE2

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

Sponsor: Tarsus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2026-03-09

Completion Date

2027-12

Last Updated

2026-05-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

TP-05 (lotilaner) Low Dose

TP05 administered orally at the protocol-defined preventative dose.

DRUG

TP-05 (lotilaner) High Dose

TP05 administered orally at the protocol-defined preventative dose.

DRUG

Placebo

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