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

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

Study Overview

• Status: Recruiting
• Conditions: Lyme Disease
• Intervention / Treatment: Drug: TP-05 (lotilaner) High Dose; Drug: Placebo; Drug: TP-05 (lotilaner) Low Dose

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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 949-418-1801

Study Locations

• United States
  • Maryland
    • Pikesville, Maryland, United States, 21208
      • Recruiting
      • Study Site
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Recruiting
      • Study Site
    • Fall River, Massachusetts, United States, 02723
      • Recruiting
      • Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Recruiting
      • Study Site
  • New Jersey
    • Marlboro, New Jersey, United States, 07746
      • Recruiting
      • Study Site
  • New York
    • Albany, New York, United States, 12205
      • Recruiting
      • Study Site
    • Binghamton, New York, United States, 13905
      • Recruiting
      • Study Site
    • Buffalo, New York, United States, 14217
      • Recruiting
      • Study Site
    • East Syracuse, New York, United States, 13057
      • Recruiting
      • Study Site
    • Middletown, New York, United States, 10941
      • Recruiting
      • Study Site
    • New York, New York, United States, 10036
      • Recruiting
      • Study Site
    • Rochester, New York, United States, 14609
      • Recruiting
      • Study Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Recruiting
      • Study Site
    • Hatboro, Pennsylvania, United States, 19040
      • Recruiting
      • Study Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Study Site
    • Pittsburgh, Pennsylvania, United States, 15236
      • Recruiting
      • Study Site
    • Pottstown, Pennsylvania, United States, 19464
      • Recruiting
      • Study Site
    • West Chester, Pennsylvania, United States, 19380
      • Recruiting
      • Study Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Recruiting
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Hematology Laboratory Tests	Number of participants with clinically significant changes in clinical laboratory tests.	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Vital Signs	Number of participants with clinically significant changes in vital signs.	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate [beats/min].	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate [msec].	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QTC Interval	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval	From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QRS Interval	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.	From day 1 through the end of study follow up, an average of 15 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Lotilaner in Whole Blood	Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays.	From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner	Terminal elimination half life (t½) of lotilaner.	At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner	Area under the concentration time curve (AUC) of lotilaner.	At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum Observed Concentration (Cmax) of Lotilaner	Maximum observed concentration (Cmax) of lotilaner.	At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to Maximum Observed Concentration (Tmax) of Lotilaner	Time to maximum observed concentration (Tmax) of lotilaner.	At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Collaborators: PPD Development, LP

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Randomized Controlled Trial; Gram-Negative Bacterial Infections; Bacterial Infections; Lyme; Borrelia; Lyme Disease; Infections; Prophylaxis; Lyme Borreliosis; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Preventative Therapeutic; Spirochaetales Infections; Vector Borne Diseases
• Additional Relevant MeSH Terms: Vector Borne Diseases; Lyme Disease; Infections; Bacterial Infections; Gram-Negative Bacterial Infections; Borrelia Infections; Tick-Borne Diseases; Bacterial Infections and Mycoses; Spirochaetales Infections; lotilaner
• Other Study ID Numbers: TRS-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No