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
Tarsus Pharmaceuticals, Inc.
700 participants
Mar 9, 2026
INTERVENTIONAL
Conditions
Summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
TP05 administered orally at the protocol-defined preventative dose.
TP05 administered orally at the protocol-defined preventative dose.
Matching placebo administered orally according to the same dosing schedule as TP05.
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07562087