TP-05 for Tick Prevention in Healthy Subjects

Overseen By Linden Hu, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Tarsus Pharmaceuticals, Inc.

Must not be taking: St. John's wort

Disqualifiers: Pregnancy, Cardiovascular disease, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 303

Duration: 60 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TP-05 to determine if it can safely prevent ticks from attaching to human skin. Participants will receive either a low dose, a high dose of TP-05, or a placebo (a pill with no active medicine) to compare the effects. The trial aims to assess the treatment's effectiveness and safety. Healthy, non-smoking individuals without significant medical issues might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking most non-prescription or prescription drugs, except for hormonal contraceptives, hormone replacement therapy, and acetaminophen, at least 7 days before starting the study. If the drug is a potential enzyme inducer, you need to stop 14 days before. Please check with the study team for specific guidance on your medications.

Is there any evidence suggesting that TP-05 is likely to be safe for humans?

Research has shown that TP-05 (lotilaner) is generally safe for people. In an earlier study, healthy adults handled TP-05 well, with most experiencing no serious side effects. These results supported further testing.

For those considering joining a trial with TP-05, current information suggests it is likely safe. However, discussing any concerns or questions with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional tick prevention methods that often involve topical solutions or repellents, TP-05 offers a novel approach by using lotilaner, an active ingredient typically used in veterinary medicine. Researchers are excited about TP-05 because it is administered orally, potentially providing a more convenient and consistent method of tick prevention for humans. Additionally, the use of lotilaner targets ticks by interfering with their nervous system, which could offer a more effective solution compared to current options that rely on repelling ticks. This innovative approach could lead to a significant advancement in protecting people from tick-borne diseases.

What evidence suggests that TP-05 might be an effective treatment for tick prevention?

Research has shown that TP-05 (lotilaner) effectively kills ticks. In a recent study, both high and low doses of TP-05 performed well, eliminating 97% and 92% of ticks on the first day. By day 30, the treatment remained effective, with 89% and 91% of ticks killed for the high and low doses, respectively. Participants in this trial will receive either a high dose, a low dose of TP-05, or a placebo. TP-05 can quickly kill ticks after they attach to the skin. Overall, these results suggest that TP-05 could help prevent problems caused by ticks. ^{1 6 7 8 9}

Who Is on the Research Team?

Linden Hu, MD

Principal Investigator

Tufts University School of Medicine

Kavita Dhamdhere, MD, PhD

Principal Investigator

Tarsus Pharmaceuticals, Inc.

Yoav Golan

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

This trial is for non-smoking or ex-smoking healthy adults aged 18-59 with a BMI of 18-32 kg/m^2. Participants must be in good health, not have significant medical conditions, and agree to use contraception. They should be willing to follow study procedures and not have any history of severe reactions to tick bites or certain chronic diseases.

Inclusion Criteria

Participants must be non- or ex-smokers

Participants must be overtly healthy as determined by medical evaluation, with no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

I have a serious health condition affecting my heart, lungs, blood, nerves, mental health, hormones, immune system, or skin.

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 of clinically significant ECG abnormalities at Screening, as defined by the Investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either low dose or high dose of TP-05 or placebo, with tick placement and mortality assessment

60 days

Multiple visits (in-person) on Day -1, Day 1, Day 2, Day 30, and Day 31

Follow-up

Participants are monitored for safety and effectiveness after treatment, including additional safety and PK visits

241 days

Multiple visits (in-person) through Day 301

What Are the Treatments Tested in This Trial?

Interventions

• TP-05

Trial Overview The study tests the safety and effectiveness of TP-05 (lotilaner) at low and high doses compared to a placebo in killing ticks on human skin. It's a Phase 2a, randomized, double-blind trial where participants won't know if they're getting TP-05 or an inactive substance.

How Is the Trial Designed?

Group I: Low Dose of TP-05 (lotilaner) Experimental Treatment 1 Intervention

Single Oral Low Dose of TP-05 tablet.

Group II: High Dose of TP-05 (lotilaner) Experimental Treatment 1 Intervention

Single Oral High Dose of TP-05 tablet.

Group III: Placebo Placebo Group 1 Intervention

Single Oral Dose of placebo tablet.

Who Is Running the Clinical Trial?

Tarsus Pharmaceuticals, Inc.

Lead Sponsor

Trials

10

Recruited

1,300+

Citations

1. ir.tarsusrx.com ir.tarsusrx.com/news-releases/news-release-details/tarsus-announces-positive-topline-results-carpo-phase-2a-proof

News Release TP-05 showed statistically significant tick mortality, with 97% and 92% mortality at day 1, and 89% and 91% at day 30 for high and low doses, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05387083

NCT05387083 | A Human Tick Kill Study to Investigate the ... 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 ...

3. parasitesandvectors.biomedcentral.com parasitesandvectors.biomedcentral.com/articles/10.1186/s13071-024-06363-w

Comparative speed of kill provided by lotilaner (Credelio ... Relative to the untreated control group, mean live tick count reductions in the lotilaner group were first significant at 12 h postinfestation ( ...

4. synapse.patsnap.com synapse.patsnap.com/article/positive-phase-2a-carpo-trial-outcomes-for-tp-05-lyme-disease-prevention

Positive Phase 2a Carpo Trial Outcomes for TP-05 Lyme ... The results showed that both high and low doses of TP-05 significantly outperformed the placebo in killing ticks, with a mean mortality rate of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6171179/

Laboratory evaluation of the efficacy of lotilaner (Credelio ... Lotilaner was considered effective if the average live tick attachment rate in the control group was at least 25%, if there was a ...

6. ir.tarsusrx.com ir.tarsusrx.com/news-releases/news-release-details/tarsus-announces-positive-topline-data-phase-1b-callisto-trial

News Release Positive Phase 1b Callisto data shows that TP-05 is well tolerated and safety data supports progression to Phase 2a. Phase 2a Carpo trial to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10678042/

2520. A Phase 1b Study of the Safety, Pharmacokinetics ... TP-05 was generally safe and well tolerated among healthy adult subjects. Data from this study supports TP-05's mechanism of action and ...

8. withpower.com withpower.com/trial/phase-2-healthy-subjects-hs-6-2022-2a33a

TP-05 for Tick Prevention in Healthy Subjects The study tests the safety and effectiveness of TP-05 (lotilaner) at low and high doses compared to a placebo in killing ticks on human skin.

9. drug-dev.com drug-dev.com/tarsus-announces-positive-topline-data-from-phase-1b-callisto-trial-initiates-phase-2a-carpo-human-tick-kill-trial-evaluating-tp-05-a-novel-oral-therapeutic-for-the-prevention-of-lyme-disease/

Tarsus Announces Positive Topline Data from Phase 1b ... TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease ...