Active, Not Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID07562087
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
Led by Tarsus Pharmaceuticals, Inc. · Updated on 2026-07-09
722
Participants Needed
19
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
Tarsus Pharmaceuticals, Inc.
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
CONDITIONS
Brief Title
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
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
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