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

Phase 2Active Not RecruitingNCT07562087

Tarsus Pharmaceuticals, Inc.722 enrolled

Overview

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

This is a randomized, double-blind, placebo-controlled study conducted in healthy adult participants prior to anticipated exposure to Lyme Borreliosis. Participants will be randomized to receive either TP05 or placebo according to a predefined dosing schedule. Safety will be evaluated through adverse event monitoring, clinical laboratory assessments, vital signs, and physical examinations. The study will consist of a screening period, a treatment period (up to 24 weeks) and a safety follow up period. Participants will be randomized to receive one of two treatment regimens of TP-05 or placebo. Participants will be followed up for approximately 15 months and evaluated further for tick bites or symptoms of Lyme borreliosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

722

Conditions

Lyme Disease

Interventions

TP-05 (lotilaner) Low DoseDRUG

TP05 administered orally at the protocol-defined preventative dose.

TP-05 (lotilaner) High DoseDRUG

TP05 administered orally at the protocol-defined preventative dose.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (19)

Study Site

Pikesville, Maryland, United States

Study Site

Brookline, Massachusetts, United States

Outcomes

Primary Outcomes

The Incidence of Treatment Emergent Adverse Events From Baseline

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

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

Clinically Significant Changes From Baseline Chemistry Laboratory Tests

Number of participants with clinically significant changes in clinical laboratory tests