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.
Summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
Description
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.…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 v…
Interventions
- DrugTP-05 (lotilaner) Low Dose
TP05 administered orally at the protocol-defined preventative dose.
- DrugTP-05 (lotilaner) High Dose
TP05 administered orally at the protocol-defined preventative dose.
- DrugPlacebo
Matching placebo administered orally according to the same dosing schedule as TP05.
Locations (19)
- Study SitePikesville, Maryland
- Study SiteBrookline, Massachusetts
- Study SiteFall River, Massachusetts
- Study SiteMinneapolis, Minnesota
- Study SiteMarlboro, New Jersey
- Study SiteAlbany, New York