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

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes TP05 when taken orally by healthy adults who are at high risk of tick exposure. This Phase 2b study is randomized, double-blind, and placebo-controlled, aiming to gather important safety and effectiveness data before potential Lyme Borreliosis exposure. The trial is sponsored by Tarsus Pharmaceuticals, Inc. and includes adults aged 18 to 70 years. Participants will be randomly assigned to receive either a high dose or low dose of TP05, or a matching placebo, following a set dosing schedule. The study includes a screening period, a treatment period lasting up to 24 weeks, and a safety follow-up period. The treatment is given orally as tablets, and participants will be monitored for about 15 months to check for tick bites or signs of Lyme borreliosis. During the trial, participants will undergo regular safety assessments including monitoring for adverse events, blood chemistry, blood counts, vital signs, physical exams, and heart monitoring via ECGs. Researchers will also measure drug levels and how the drug is cleared from the body. Follow-up visits will continue for an average of 15 months to ensure participant safety and evaluate any symptoms related to tick exposure.

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