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

Last updated: September 10, 2024
Sponsor: Tarsus Pharmaceuticals, Inc.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

High Dose TP-05

Placebo Comparator

Low Dose TP-05

Clinical Study ID

NCT05387083
TRS-015
  • Ages 18-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be 18 to 59 years of age inclusive, at the time of signing theinformed consent.

  2. Participants who are overtly healthy as determined by medical evaluation includinghaving no clinically significant diseases captured in the medical history orevidence 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 ofthe 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

Exclusion Criteria:

  1. Female who is lactating at Screening.

  2. Female who is pregnant according to the serum pregnancy test at Screening or priorto study treatment administration.

  3. History of significant hypersensitivity to lotilaner or any related products (including excipients of the formulations) as well as severe hypersensitivityreactions (like angioedema) to any drugs.

  4. Presence or history of significant gastrointestinal, metabolic, liver or kidneydisease, 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 treatedbasal cell or squamous cell carcinoma.

  7. Presence of clinically significant ECG abnormalities at Screening, as defined by theInvestigator.

  8. Maintenance therapy with any drug or significant history of drug dependency oralcohol abuse.

  9. Any clinically significant illness in the 28 days prior to study treatmentadministration.

  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 hormonalcontraceptives, hormone replacement therapy, acetaminophen) in the 7 days (or 14days if the drug is a potential enzyme inducer) or 5 half-lives (whichever islonger) 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 orrequirement to receive these vaccinations at any time during the study.

  18. Any other clinically significant abnormalities in laboratory test results atScreening that would, in the opinion of the Investigator, increase the participant'srisk of participation, jeopardize complete participation in the study, or compromiseinterpretation 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.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: High Dose TP-05
Phase: 2
Study Start date:
December 12, 2022
Estimated Completion Date:
June 26, 2024

Study Description

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.

Connect with a study center

  • Tufts University School of Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

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