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.

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.

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