A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05

Study Purpose

This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human skin.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 59 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical evaluation including having no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination. 3. Participants who are non- or ex-smokers. 4. Willingness to comply with all study procedures and availability for the duration of the study. 5. BMI within the range 18
  • - 32 kg/m2.
6. Willingness to comply with contraceptive requirements. 7. Capable of giving signed informed consent.

Exclusion Criteria:

1. Female who is lactating at Screening. 2. Female who is pregnant according to the serum pregnancy test at Screening or prior to study treatment administration. 3. History of significant hypersensitivity to lotilaner or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. 4. Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy). 5. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease. 6. Have a history of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma. 7. Presence of clinically significant ECG abnormalities at Screening, as defined by the Investigator. 8. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse. 9. Any clinically significant illness in the 28 days prior to study treatment administration. 10. Known history of chronic infectious disease. 11. History of allergy to surgical tape, hydrocolloid, or dressing. 12. History of severe reactions to tick bites (granuloma or systemic reactions). 13. Use of any non-prescription or prescription drugs (with the exception of hormonal contraceptives, hormone replacement therapy, acetaminophen) in the 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study treatment administration. 14. Use of St. John's wort in the 28 days prior to study treatment administration. 15. Intake of lotilaner in the 6 months prior to study treatment administration. 16. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening. 17. History of live attenuated vaccine within 4 weeks prior to randomization or requirement to receive these vaccinations at any time during the study. 18. Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of the Investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. 19. Blood donation of approximately 500 mL within 56 days prior to Screening. 20. Plasma donation within 7 days prior to Screening.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tarsus Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jose Trevejo, CMOLinden Hu, MDYoav Golan
Principal Investigator Affiliation Tarsus Pharmaceuticals, Inc.Tufts University School of MedicineTufts Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Healthy Volunteer
Additional Details

The study will consist of a screening period of no more than 30 days. Participants will come to the study center on Day -1 for tick placements on the skin. Nymphal ticks that have been tested negative for human pathogens and are known to be ready to attach will be placed. On Day 1, the number of attached, live ticks will be counted. Participants will be randomized on Day 1 to receive either low dose or high dose of TP-05 or placebo. Tick attachment and mortality will be completed on Day 1 and after participants' return to the study center on Day 2 (24 hours after dosing). Participants will have ticks removed from the skin at the study center after the Day 2 (24 hours) tick count. Participants will come to the study center on Day 30 for another placement of ticks on the skin. Tick attachment and mortality will be determined on Day 30 and on Day 31 (24 hours after placement). Participants will complete the treatment period at Day 60. Participants will undergo a long-term safety follow-up period which will include additional safety and PK visits through Day 301.

Arms & Interventions


Experimental: Low Dose of TP-05 (lotilaner)

Single Oral Low Dose of TP-05 tablet.

Experimental: High Dose of TP-05 (lotilaner)

Single Oral High Dose of TP-05 tablet.

Placebo Comparator: Placebo

Single Oral Dose of placebo tablet.


Drug: - Low Dose TP-05

Healthy Volunteers will receive a single low dose of TP-05 on Day 1.

Drug: - High Dose TP-05

Healthy Volunteers will receive a single high dose of TP-05 on Day 1.

Drug: - Placebo Comparator

Healthy Volunteers will receive a single dose of placebo on Day 1.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tufts University School of Medicine, Boston, Massachusetts




Tufts University School of Medicine

Boston, Massachusetts, 02111

Site Contact

Rupali Ranade

[email protected]