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

Conditions: Lyme Disease

Sex: All

Ages: 18 Years – 70 Years

Healthy volunteers: Yes

Phase: PHASE2

Enrollment: 722

Sponsor: Tarsus Pharmaceuticals, Inc.

Location: Study Site Pikesville Maryland

Summary

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

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07562087). StuddyBuddy aggregates publicly available trial information.