A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
- Summary
- This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
- Short title
- A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2026-05-01
- Registry last updated
- 2026-07-09
- Primary completion date
- 2027-10-01
- Start date
- 2026-03-09
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07562087
- ClinicalTrials.gov ID
- NCT07562087
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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.
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
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.
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.
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 \[beats/min\].
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 \[msec\].
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
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.
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.
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.
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.
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.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- Yes
- 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
- 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
- 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