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

Tarsus Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Lyme Disease

Treatments: Drug: TP-05 (lotilaner) High Dose; Drug: Placebo; Drug: TP-05 (lotilaner) Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT07562087

TRS-018

Details and patient eligibility

About

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

Full 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. Participants will be followed up for approximately 15 months and evaluated further for tick bites or symptoms of Lyme borreliosis.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 3 patient groups, including a placebo group

TP-05 (lotilaner) High Dose

Active Comparator group

Description:

Oral Tablet

Treatment:

Drug: TP-05 (lotilaner) High Dose

Placebo

Placebo Comparator group

Description:

Oral Tablet

Treatment:

Drug: Placebo

TP-05 (lotilaner) Low Dose

Active Comparator group

Description:

Oral Tablet

Treatment:

Drug: TP-05 (lotilaner) Low Dose