Phase
Condition
N/ATreatment
High Dose TP-05
Placebo Comparator
Low Dose TP-05
Clinical Study ID
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 18 to 59 years of age inclusive, at the time of signing theinformed consent.
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.
Participants who are non- or ex-smokers.
Willingness to comply with all study procedures and availability for the duration ofthe study.
BMI within the range 18 - 32 kg/m2
Willingness to comply with contraceptive requirements
Capable of giving signed informed consent
Exclusion
Exclusion Criteria:
Female who is lactating at Screening.
Female who is pregnant according to the serum pregnancy test at Screening or priorto study treatment administration.
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.
Presence or history of significant gastrointestinal, metabolic, liver or kidneydisease, 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 treatedbasal cell or squamous cell carcinoma.
Presence of clinically significant ECG abnormalities at Screening, as defined by theInvestigator.
Maintenance therapy with any drug or significant history of drug dependency oralcohol abuse.
Any clinically significant illness in the 28 days prior to study treatmentadministration.
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 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.
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 orrequirement to receive these vaccinations at any time during the study.
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.
Blood donation of approximately 500 mL within 56 days prior to Screening.
Plasma donation within 7 days prior to Screening.
Study Design
Study Description
Connect with a study center
Tufts University School of Medicine
Boston, Massachusetts 02111
United StatesSite Not Available
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