NCT07562087Phase 2Active not recruiting

A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure

Study sponsor: Tarsus Pharmaceuticals, Inc. · TARS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-10Estimated

Enrollment · participants722Actual

Source updated2026-07-09Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-09 · 3 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~700 participants (planned)~~

+ After

722 participants (actual)

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Lyme Disease

Treatments or interventions studied

TP-05 (lotilaner) Low DoseDrug
TP-05 (lotilaner) High DoseDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: The Incidence of Treatment Emergent Adverse Events From Baseline; description: Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.; timeFrame: From day 1 through the end of study follow-up, an average of 15 months.; measure: Clinically Significant Changes From Baseline Chemistry Laboratory Tests; description: Number of participants with clinically significant changes in clinical laboratory tests; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline Hematology Laboratory Tests; description: Number of participants with clinically significant changes in clinical laboratory tests.; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline Vital Signs; description: Number of participants with clinically significant changes in vital signs.; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline Electrocardiograms (ECGs); description: Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures; description: Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline QTC Interval; description: Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval; timeFrame: From day 1 through the end of study follow up, an average of 15 months.; measure: Clinically Significant Changes From Baseline QRS Interval; description: Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.; timeFrame: From day 1 through the end of study follow up, an average of 15 months.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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