Status:
COMPLETED
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
Lead Sponsor:
Tarsus Pharmaceuticals, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief 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 afte...
Detailed 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...
Eligibility Criteria
Inclusion
- Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent.
- 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.
- Participants who are non- or ex-smokers.
- Willingness to comply with all study procedures and availability for the duration of the study.
- BMI within the range 18 - 32 kg/m2
- Willingness to comply with contraceptive requirements
- Capable of giving signed informed consent
Exclusion
- Female who is lactating at Screening.
- Female who is pregnant according to the serum pregnancy test at Screening or prior to study treatment administration.
- 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.
- Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy).
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
- Have a history of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma.
- Presence of clinically significant ECG abnormalities at Screening, as defined by the Investigator.
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse.
- Any clinically significant illness in the 28 days prior to study treatment administration.
- Known history of chronic infectious disease.
- History of allergy to surgical tape, hydrocolloid, or dressing.
- History of severe reactions to tick bites (granuloma or systemic reactions).
- 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.
- Use of St. John's wort in the 28 days prior to study treatment administration.
- Intake of lotilaner in the 6 months prior to study treatment administration.
- Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening.
- History of live attenuated vaccine within 4 weeks prior to randomization or requirement to receive these vaccinations at any time during the study.
- 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.
- Blood donation of approximately 500 mL within 56 days prior to Screening.
- Plasma donation within 7 days prior to Screening.
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05387083
Start Date
December 12 2022
End Date
June 26 2024
Last Update
September 19 2024
Active Locations (1)
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1
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111