A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
ConditionLyme Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTarsus Pharmaceuticals, Inc.
About this trial
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TP-05 (lotilaner) Low Dose
- TP-05 (lotilaner) High Dose
- Placebo
Treatment groups
700 Participants
are divided into 3 treatment groupsSponsors and collaborators
Tarsus Pharmaceuticals, Inc.
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov