A Phase 2 interventional study of TP-05 (lotilaner) Low Dose and TP-05 (lotilaner) High Dose in Lyme Disease, sponsored by Tarsus Pharmaceuticals, Inc.. Active, not recruiting at 19 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
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.
97 studies on the registry are indexed under Lyme Disease; 26 are open to participants now.
This study's enrollment of 722 is above the median of 120 across 52 interventional studies indexed under Lyme Disease.
Browse Lyme Disease studies →Tarsus Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral Tablet
Drug: TP-05 (lotilaner) High Dose
Oral Tablet
Drug: Placebo
Oral Tablet
Drug: TP-05 (lotilaner) Low Dose
TP05 administered orally at the protocol-defined preventative dose.
TP05 administered orally at the protocol-defined preventative dose.
Matching placebo administered orally according to the same dosing schedule as TP05.
The Incidence of Treatment Emergent Adverse Events From Baseline
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Time frame: From day 1 through the end of study follow-up, an average of 15 months.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Hematology Laboratory Tests
Number of participants with clinically significant changes in clinical laboratory tests.
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Vital Signs
Number of participants with clinically significant changes in vital signs.
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QTC Interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QRS Interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.
Time frame: From day 1 through the end of study follow up, an average of 15 months.
Concentration of Lotilaner in Whole Blood
Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays.
Time frame: From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner
Terminal elimination half life (t½) of lotilaner.
Time frame: At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner
Area under the concentration time curve (AUC) of lotilaner.
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Maximum Observed Concentration (Cmax) of Lotilaner
Maximum observed concentration (Cmax) of lotilaner.
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Time to Maximum Observed Concentration (Tmax) of Lotilaner
Time to maximum observed concentration (Tmax) of lotilaner.
Time frame: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Tarsus Pharmaceuticals, Inc.