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

NCT07562087 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TRS-018
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Lyme Disease

Keywords

Lyme Disease; Lyme Borreliosis; Lyme; Borrelia; Preventative Therapeutic; Prophylaxis; Healthy Volunteers; Randomized Controlled Trial; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Concentration of Lotilaner in Whole Blood

  From dose through study completion, an average of 15 months.

• 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

  At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.

• 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

  At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.

Study Arms (3)

TP-05 (lotilaner) High Dose

ACTIVE COMPARATOR

Oral Tablet

Drug: TP-05 (lotilaner) High Dose

Placebo

PLACEBO COMPARATOR

Oral Tablet

Drug: Placebo

TP-05 (lotilaner) Low Dose

ACTIVE COMPARATOR

Oral Tablet

Drug: TP-05 (lotilaner) Low Dose

Interventions

TP-05 (lotilaner) Low Dose DRUG

TP05 administered orally at the protocol-defined preventative dose.

TP-05 (lotilaner) Low Dose

TP-05 (lotilaner) High Dose DRUG

TP05 administered orally at the protocol-defined preventative dose.

TP-05 (lotilaner) High Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PPD Development, LP: collaborator
• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (19)

Study Site

Pikesville, Maryland, 21208, United States

RECRUITING

Study Site

Brookline, Massachusetts, 02445, United States

RECRUITING

Study Site

Fall River, Massachusetts, 02723, United States

NOT YET RECRUITING

Study Site

Minneapolis, Minnesota, 55402, United States

RECRUITING

Study Site

Marlboro, New Jersey, 07746, United States

RECRUITING

Study Site

Albany, New York, 12205, United States

RECRUITING

Study Site

Binghamton, New York, 13905, United States

RECRUITING

Study Site

Buffalo, New York, 14217, United States

RECRUITING

Study Site

East Syracuse, New York, 13057, United States

RECRUITING

Study Site

Middletown, New York, 10941, United States

RECRUITING

Study Site

New York, New York, 10036, United States

RECRUITING

Study Site

Rochester, New York, 14609, United States

RECRUITING

Study Site

Erie, Pennsylvania, 16508, United States

RECRUITING

Study Site

Hatboro, Pennsylvania, 19040, United States

RECRUITING

Study Site

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Study Site

Pittsburgh, Pennsylvania, 15236, United States

RECRUITING

Study Site

Pottstown, Pennsylvania, 19464, United States

RECRUITING

Study Site

West Chester, Pennsylvania, 19380, United States

RECRUITING

Study Site

Warwick, Rhode Island, 02886, United States

RECRUITING

MeSH Terms

Conditions

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Interventions

lotilaner

Central Study Contacts

Study Director

CONTACT

949-418-1801

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: May 1, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)