A Phase 2 interventional study of Low Dose TP-05 and High Dose TP-05 in Healthy Volunteer, sponsored by Tarsus Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2, Interventional, and Other
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.
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.
97 studies on the registry are indexed under Lyme Disease; 26 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 52 interventional studies indexed under Lyme Disease.
Browse Lyme Disease studies →Tarsus Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Oral Low Dose of TP-05 tablet.
Drug: Low Dose TP-05
Single Oral High Dose of TP-05 tablet.
Drug: High Dose TP-05
Single Oral Dose of placebo tablet.
Drug: Placebo Comparator
Healthy Volunteers will receive a single low dose of TP-05 on Day 1.
Also known as: Lotilaner
Healthy Volunteers will receive a single high dose of TP-05 on Day 1.
Also known as: Lotilaner
Healthy Volunteers will receive a single dose of placebo on Day 1.
Also known as: Placebo
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.
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline chemistry laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline hematology laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline vital signs
Number of participants with clinically significant changes in vital signs.
Time frame: 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 \[beats/min\]
Time frame: 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 \[msec\]
Time frame: 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
Time frame: 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
Time frame: Day -1 through Day 301
Evaluate the concentration of lotilaner in whole blood
Measure of concentration of lotilaner in whole blood at specified timepoints
Time frame: Day -1 through Day 301
TP-05 on Tick Mortality
Evaluate Tick Mortality after TP-05 administration.
Time frame: Day 2 through Day 31
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Jun 2024, 18 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lotilaner
Tarsus Pharmaceuticals, Inc.