TP-05 for Lyme Disease Prevention

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tarsus Pharmaceuticals, Inc.

Must not be taking: Investigational products, Long-term antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Lyme vaccination, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 70 years old and in good health.

Willing and able to comply with study procedures

Able to provide written informed consent

Exclusion Criteria

Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis

I am currently taking antibiotics for a long period of time.

I have had a vaccine or immunization in the past 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TP-05 or placebo according to a predefined dosing schedule

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation for tick bites or symptoms of Lyme borreliosis

15 months

What Are the Treatments Tested in This Trial?

Interventions

• TP-05

How Is the Trial Designed?

Group I: TP-05 (lotilaner) High Dose Active Control 1 Intervention

Oral Tablet

Group II: TP-05 (lotilaner) Low Dose Active Control 1 Intervention

Oral Tablet

Group III: Placebo Placebo Group 1 Intervention

Oral Tablet

Who Is Running the Clinical Trial?

Tarsus Pharmaceuticals, Inc.

Lead Sponsor

Trials

10

Recruited

1,300+

PPD Development, LP

Industry Sponsor