NCT05387083Phase 2Completed

A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05

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 completion2024-06-26Actual

Enrollment · participants30Actual

Source updated2024-09-19Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Healthy Volunteer

Treatments or interventions studied

Low Dose TP-05DrugAlso known as Lotilaner
High Dose TP-05DrugAlso known as Lotilaner
Placebo ComparatorDrugAlso known as Placebo

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: Day -1 through Day 301; measure: Clinically significant changes from Baseline chemistry laboratory tests; description: Number of participants with clinically significant changes in clinical laboratory tests; timeFrame: Day -1 through Day 301; measure: Clinically significant changes from Baseline hematology laboratory tests; description: Number of participants with clinically significant changes in clinical laboratory tests; timeFrame: Day -1 through Day 301; measure: Clinically significant changes from Baseline vital signs; description: Number of participants with clinically significant changes in vital signs.; timeFrame: Day -1 through Day 301; 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: Day -1 through Day 301; 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: Day -1 through Day 301; 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: Day -1 through Day 301; 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: Day -1 through Day 301

History coverage

Imported research includes version dates later than the current official API record (2024-09-19). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. 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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