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

A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Single-Center, Human Tick Kill Proof-of-Concept Study Evaluating the Safety, Tolerability, and Whole Blood Concentration of TP-05 (Lotilaner) in Healthy Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Low Dose TP-05; Drug: High Dose TP-05; Drug: Placebo Comparator

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jeremy Lim, PharmD; Phone Number: 949-344-2657; Email: JLim@tarsusrx.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose of TP-05 (lotilaner); Single Oral Low Dose of TP-05 tablet.	Drug: Low Dose TP-05; Healthy Volunteers will receive a single low dose of TP-05 on Day 1.; Other Names: Lotilaner
Experimental: High Dose of TP-05 (lotilaner); Single Oral High Dose of TP-05 tablet.	Drug: High Dose TP-05; Healthy Volunteers will receive a single high dose of TP-05 on Day 1.; Other Names: Lotilaner
Placebo Comparator: Placebo; Single Oral Dose of placebo tablet.	Drug: Placebo Comparator; Healthy Volunteers will receive a single dose of placebo on Day 1.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day -1 through Day 301
Clinically significant changes from Baseline chemistry laboratory tests	Number of participants with clinically significant changes in clinical laboratory tests	Day -1 through Day 301
Clinically significant changes from Baseline hematology laboratory tests	Number of participants with clinically significant changes in clinical laboratory tests	Day -1 through Day 301
Clinically significant changes from Baseline vital signs	Number of participants with clinically significant changes in vital signs.	Day -1 through Day 301
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]	Day -1 through Day 301
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]	Day -1 through Day 301
Clinically significant changes from Baseline QTC interval	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval	Day -1 through Day 301
Clinically significant changes from Baseline QRS interval	Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval	Day -1 through Day 301

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TP-05 on Tick Mortality	Evaluate Tick Mortality after TP-05 administration.	Day 2 through Day 31
Evaluate the concentration of lotilaner in whole blood	Measure of concentration of lotilaner in whole blood at specified timepoints	Day -1 through Day 301

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Study Director: Jose Trevejo, CMO, Tarsus Pharmaceuticals, Inc.; Principal Investigator: Linden Hu, MD, Tufts University School of Medicine; Principal Investigator: Yoav Golan, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): June 27, 2024
• Study Completion (Estimated): June 27, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lyme Disease; Ticks
• Other Study ID Numbers: TRS-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No