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Healthy VolunteerPhase 2NCT05387083

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

A Phase 2 study testing Low Dose TP-05 and High Dose TP-05 in people with Healthy Volunteer, run by Tarsus Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Low Dose TP-05 and High Dose TP-05
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Dec 2022to 26 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Low Dose TP-05, High Dose TP-05, Placebo Comparator
Keywords
Lyme Disease, Ticks
Medical subject headings
Lyme Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose TP-05Drug

    Also called Lotilaner

    Healthy Volunteers will receive a single low dose of TP-05 on Day 1.

  • High Dose TP-05Drug

    Also called Lotilaner

    Healthy Volunteers will receive a single high dose of TP-05 on Day 1.

  • Placebo ComparatorDrug

    Also called Placebo

    Healthy Volunteers will receive a single dose of placebo on Day 1.

Study groups in NCT05387083
Study groupRoleWhat they receive
Low Dose of TP-05 (lotilaner)ExperimentalSingle Oral Low Dose of TP-05 tablet.
Receives: Drug: Low Dose TP-05
High Dose of TP-05 (lotilaner)ExperimentalSingle Oral High Dose of TP-05 tablet.
Receives: Drug: High Dose TP-05
PlaceboPlacebo comparatorSingle Oral Dose of placebo tablet.
Receives: Drug: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day -1 through Day 301

  2. Clinically significant changes from Baseline chemistry laboratory tests

    Number of participants with clinically significant changes in clinical laboratory tests

    Measured: Day -1 through Day 301

  3. Clinically significant changes from Baseline hematology laboratory tests

    Number of participants with clinically significant changes in clinical laboratory tests

    Measured: Day -1 through Day 301

  4. Clinically significant changes from Baseline vital signs

    Number of participants with clinically significant changes in vital signs.

    Measured: Day -1 through Day 301

  5. 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]

    Measured: Day -1 through Day 301

  6. 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]

    Measured: Day -1 through Day 301

  7. Clinically significant changes from Baseline QTC interval

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval

    Measured: Day -1 through Day 301

  8. Clinically significant changes from Baseline QRS interval

    Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval

    Measured: Day -1 through Day 301

Secondary outcomes (2)

  1. Evaluate the concentration of lotilaner in whole blood

    Measure of concentration of lotilaner in whole blood at specified timepoints

    Measured: Day -1 through Day 301

  2. TP-05 on Tick Mortality

    Evaluate Tick Mortality after TP-05 administration.

    Measured: Day 2 through Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start12 Dec 2022
  3. Primary completion26 Jun 2024
  4. Study completion26 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387083
Sponsor's protocol ID
TRS-015
Status last verified
Sep 2024
First submitted
3 May 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose TP-05 and High Dose TP-05 in people with Healthy Volunteer, run by Tarsus Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of treatment emergent adverse events from baseline (time frame: Day -1 through Day 301). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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Clinical Trial NCT05387083 | AzTrials