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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Lyme Disease

In brief

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

Key facts

Study ID

NCT07562087

Run by

Tarsus Pharmaceuticals, Inc.

People needed

722

Starts

2026-03-09

Expected to finish

2027-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Study Site — Pikesville, Maryland, United States
• Study Site — Brookline, Massachusetts, United States
• Study Site — Fall River, Massachusetts, United States
• Study Site — Minneapolis, Minnesota, United States
• Study Site — Marlboro, New Jersey, United States
• Study Site — Albany, New York, United States
• Study Site — Binghamton, New York, United States
• Study Site — Buffalo, New York, United States
• Study Site — East Syracuse, New York, United States
• Study Site — Middletown, New York, United States
• Study Site — New York, New York, United States
• Study Site — Rochester, New York, United States
• Study Site — Erie, Pennsylvania, United States
• Study Site — Hatboro, Pennsylvania, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Pittsburgh, Pennsylvania, United States
• Study Site — Pottstown, Pennsylvania, United States
• Study Site — West Chester, Pennsylvania, United States
• Study Site — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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