deltatrials
Recruiting INTERVENTIONAL NCT07562087

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

Sponsor: PPD Development, LP

Conditions Lyme Disease
Interventions Placebo TP-05 (lotilaner) High Dose TP-05 (lotilaner) Low Dose
Updated 1 time since 2026 Last updated: Apr 24, 2026 Started: Mar 9, 2026 Primary completion: Oct 1, 2027 Completion: Dec 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07562087, this observational or N/A phase trial focuses on Lyme Disease and remains actively recruiting participants. Sponsored by PPD Development, LP, it has been updated 1 time since 2026, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

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.

Status Flow

May 4, 2026 – present · 2 months · daily APIRecruiting

Change History

1 version recorded
Recruiting [daily]

Eligibility Summary

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

Contact Information

Sponsor contact:
  • PPD Development, LP
  • Tarsus Pharmaceuticals, Inc.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Binghamton, United States , Brookline, United States , Buffalo, United States , East Syracuse, United States , Erie, United States , Fall River, United States , Hatboro, United States , Marlboro, United States , Middletown, United States and 9 more locations