A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
← catalyst calendarNCT07562087 · readout ≤ 437 d
Sponsored by Tarsus Pharmaceuticals, Inc. (industry) · TARS — their whole pipeline →. With PPD Development, LP.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
722actual
Sites
19
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-09 | actual | When the study began enrolling |
| Primary completion | Oct 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lyme Disease
Interventions
- Drug: TP-05 (lotilaner) Low Dose
- Drug: TP-05 (lotilaner) High Dose
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFThe Incidence of Treatment Emergent Adverse Events From Baseline
measured From day 1 through the end of study follow-up, an average of 15 months.
Clinically Significant Changes From Baseline Chemistry Laboratory Tests
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Hematology Laboratory Tests
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Vital Signs
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QTC Interval
measured From day 1 through the end of study follow up, an average of 15 months.
Clinically Significant Changes From Baseline QRS Interval
measured From day 1 through the end of study follow up, an average of 15 months.
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