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

September 10, 2024 updated by: Tarsus Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Incidence of treatment emergent adverse events from baseline
Time Frame: Day -1 through Day 301
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
Time Frame: Day -1 through Day 301
Number of participants with clinically significant changes in clinical laboratory tests
Day -1 through Day 301
Clinically significant changes from Baseline hematology laboratory tests
Time Frame: Day -1 through Day 301
Number of participants with clinically significant changes in clinical laboratory tests
Day -1 through Day 301
Clinically significant changes from Baseline vital signs
Time Frame: Day -1 through Day 301
Number of participants with clinically significant changes in vital signs.
Day -1 through Day 301
Clinically significant changes from Baseline electrocardiograms (ECGs)
Time Frame: Day -1 through Day 301
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
Time Frame: Day -1 through Day 301
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
Time Frame: Day -1 through Day 301
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
Time Frame: Day -1 through Day 301
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval
Day -1 through Day 301

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TP-05 on Tick Mortality
Time Frame: Day 2 through Day 31
Evaluate Tick Mortality after TP-05 administration.
Day 2 through Day 31
Evaluate the concentration of lotilaner in whole blood
Time Frame: Day -1 through Day 301
Measure of concentration of lotilaner in whole blood at specified timepoints
Day -1 through Day 301

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linden Hu, MD, Tufts University School of Medicine
  • Principal Investigator: Yoav Golan, Tufts Medical Center
  • Study Director: Kavita Dhamdhere, MD, PhD, Tarsus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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