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

Purpose

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

Condition

  • Lyme Disease

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
TP-05 (lotilaner) High Dose 		Oral Tablet
  • Drug: TP-05 (lotilaner) High Dose
    TP05 administered orally at the protocol-defined preventative dose.
Placebo Comparator
Placebo 		Oral Tablet
  • Drug: Placebo
    Matching placebo administered orally according to the same dosing schedule as TP05.
Active Comparator
TP-05 (lotilaner) Low Dose 		Oral Tablet
  • Drug: TP-05 (lotilaner) Low Dose
    TP05 administered orally at the protocol-defined preventative dose.

Recruiting Locations

Study Site
Pikesville, Maryland 21208

Study Site
Brookline, Massachusetts 02445

Study Site
Minneapolis, Minnesota 55402

Study Site
Marlboro, New Jersey 07746

Study Site
Albany, New York 12205

Study Site
Binghamton, New York 13905

Study Site
Buffalo, New York 14217

Study Site
East Syracuse, New York 13057

Study Site
Middletown, New York 10941

Study Site
New York, New York 10036

Study Site
Rochester, New York 14609

Study Site
Erie, Pennsylvania 16508

Study Site
Hatboro, Pennsylvania 19040

Study Site
Philadelphia, Pennsylvania 19107

Study Site
Pittsburgh, Pennsylvania 15236

Study Site
Pottstown, Pennsylvania 19464

Study Site
West Chester, Pennsylvania 19380

Study Site
Warwick, Rhode Island 02886

More Details

Status
Recruiting
Sponsor
Tarsus Pharmaceuticals, Inc.

Study Contact

Study Director
949-418-1801

Detailed Description

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.