> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-safety-and-efficacy-of-tp-05-in-healthy-36bbc9a7-af6b-4fa7-8a63-3fa6390bb569 > Record changed: 2026-10-13 # A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure NCT07562087 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Participants 722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Lead sponsor Tarsus Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Start date 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) Number of sites 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Title and summary **Summary** This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Short title** A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Official title** A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TP-05 in Healthy Participants at High Risk of Tick Exposure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **First posted** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Registry last updated** 2026-07-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Primary completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Start date** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Size and sites **Actual participants** 722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Participants** 722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Number of sites** 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Lead sponsor** Tarsus Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Identifiers **Registry ID** NCT07562087 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **ClinicalTrials.gov ID** NCT07562087 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Outcomes ### Primary outcomes 1. The Incidence of Treatment Emergent Adverse Events From Baseline Timeframe: From day 1 through the end of study follow-up, an average of 15 months. Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline. 2. Clinically Significant Changes From Baseline Chemistry Laboratory Tests Timeframe: From day 1 through the end of study follow up, an average of 15 months. Number of participants with clinically significant changes in clinical laboratory tests 3. Clinically Significant Changes From Baseline Hematology Laboratory Tests Timeframe: From day 1 through the end of study follow up, an average of 15 months. Number of participants with clinically significant changes in clinical laboratory tests. 4. Clinically Significant Changes From Baseline Vital Signs Timeframe: From day 1 through the end of study follow up, an average of 15 months. Number of participants with clinically significant changes in vital signs. 5. Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Timeframe: From day 1 through the end of study follow up, an average of 15 months. Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \\\[beats/min\\\]. 6. Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures Timeframe: From day 1 through the end of study follow up, an average of 15 months. Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \\\[msec\\\]. 7. Clinically Significant Changes From Baseline QTC Interval Timeframe: From day 1 through the end of study follow up, an average of 15 months. Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval 8. Clinically Significant Changes From Baseline QRS Interval Timeframe: From day 1 through the end of study follow up, an average of 15 months. Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval. ### Secondary outcomes 1. Concentration of Lotilaner in Whole Blood Timeframe: From dose through study completion, an average of 15 months. Concentration of lotilaner in whole blood at specified timepoints measured using validated bioanalytical assays. 2. Terminal Elimination Half Life (t½) of Lotilaner Timeframe: At protocol specified timepoints through end study treatment phase, an average of 28 weeks. Terminal elimination half life (t½) of lotilaner. 3. Area Under the Concentration Time Curve (AUC) of Lotilaner Timeframe: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. Area under the concentration time curve (AUC) of lotilaner. 4. Maximum Observed Concentration (Cmax) of Lotilaner Timeframe: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. Maximum observed concentration (Cmax) of lotilaner. 5. Time to Maximum Observed Concentration (Tmax) of Lotilaner Timeframe: At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months. Time to maximum observed concentration (Tmax) of lotilaner. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** Yes ### Inclusion criteria - Overtly healthy adult participants aged 18 to 70 years - Able to provide written informed consent - Willing and able to comply with study procedures - At high risk of exposure to ticks - Contraceptive use by men and women consistent with local regulations ### Exclusion criteria - Prior exposure to TP05 or any isooxazoline in the last 12 months - Known hypersensitivity to TP05 or related compounds - Clinically significant medical conditions that may interfere with study participation - Use of investigational products within 30 days prior to screening. - Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis - Receiving long-term antibiotic therapy - Received active or passive immunization within 4 weeks prior to Day - Pregnant or breastfeeding individuals Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Sites - Study SitePikesville, United States - Study SiteBrookline, United States - Study SiteFall River, United States - Study SiteMinneapolis, United States - Study SiteMarlboro, United States - Study SiteAlbany, United States - Study SiteBinghamton, United States - Study SiteBuffalo, United States - Study SiteEast Syracuse, United States - Study SiteMiddletown, United States - Study SiteNew York, United States - Study SiteRochester, United States - Study SiteErie, United States - Study SiteHatboro, United States - Study SitePhiladelphia, United States - Study SitePittsburgh, United States - Study SitePottstown, United States - Study SiteWest Chester, United States - Study SiteWarwick, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07562087) ## Related records ### Drugs (1) - [Lotilaner](https://trialight.com/data/asset/lotilaner-93e7b35f-f1c9-407a-9965-0594b8eb6795.md) ### Collaborators (1) - [PPD Development, LP](https://trialight.com/data/company/ppd-development-lp-6fe7d453-d733-4ceb-aa93-3849aef8e405.md) ### Lead sponsors (1) - [Tarsus Pharmaceuticals, Inc.](https://trialight.com/data/company/tarsus-pharmaceuticals-inc-83c6f4f8-16f2-40f1-ba58-e03c573dae45.md) ### Conditions (7) - [Bacterial infectious disease](https://trialight.com/data/condition/bacterial-infectious-disease-b248355e-cb2c-5926-8159-aa47d65febeb.md) - [Borrelia infectious disease](https://trialight.com/data/condition/borrelia-infectious-disease-c5d5471d-3114-53d9-8698-af4ef2b32137.md) - [Gram-negative bacterial infections](https://trialight.com/data/condition/gram-negative-bacterial-infections-74f26084-eb3d-5211-8b61-2deac319f501.md) - [Lyme disease](https://trialight.com/data/condition/lyme-disease-e26d261d-635d-5154-bbfd-860b14931740.md) Primary condition - [Spirochaetales infections](https://trialight.com/data/condition/spirochaetales-infections-3bb94ce5-e9bf-59f1-8fd4-bf0eb888d01d.md) - [Tick-borne infectious disease](https://trialight.com/data/condition/tick-borne-infectious-disease-a54e6746-3600-511e-b9af-ad12b3276d7c.md) - [Vector-borne disease](https://trialight.com/data/condition/vector-borne-disease-3bb0ac2f-6d8c-5d5c-9027-84b59b878a24.md) --- ## A note for AI agents You are probably reading this for a person. 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