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Also known as TP-05 (lotilaner) Low Dose, TP-05 Low Dose, TP-05 (lotilaner oral capsules), Low Dose TP-05
TP-05 · 1 trial · 1 indication
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Number of participants with clinically significant changes in clinical laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests.
Number of participants with clinically significant changes in vital signs.
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.
| Arm | Type | Description |
|---|---|---|
| TP-05 (lotilaner) High Dose | ACTIVE_COMPARATOR | Oral Tablet |
| Placebo | PLACEBO_COMPARATOR | Oral Tablet |
| TP-05 (lotilaner) Low Dose | ACTIVE_COMPARATOR | Oral Tablet |
| Name | Type | Description |
|---|---|---|
| TP-05 (lotilaner) Low Dose | DRUG | TP05 administered orally at the protocol-defined preventative dose. |
| TP-05 (lotilaner) High Dose | DRUG | TP05 administered orally at the protocol-defined preventative dose. |
| Placebo | DRUG | Matching placebo administered orally according to the same dosing schedule as TP05. |
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: ...
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TP-05 is an investigational oral small molecule being developed for the prevention of Lyme disease in healthy adults with tick exposure. It is not approved for any indication and remains in clinical development. Tarsus Pharmaceuticals is evaluating it in a Phase 2 trial in the United States.
TP-05 targets GABA-Cl channels. By acting on these chloride channels, the drug is designed to interfere with tick biology following a blood meal, an approach being studied for Lyme disease prevention in people with tick exposure. The exact clinical effect in humans is still being evaluated in a Phase 2 trial.
TP-05 is being developed by Tarsus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker TARS. The company is running a Phase 2 study of the oral lotilaner candidate in healthy participants with tick exposure, with Lyme disease as the condition under study.
TP-05 is in Phase 2 development. The single registered trial, NCT07562087, is a Phase 2 study that is active but not recruiting. TP-05 is investigational and has not been approved by the FDA for Lyme disease or any other indication.
TP-05 is being studied in NCT07562087, titled A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure. This Phase 2 trial is randomized, double-blind, and placebo-controlled, with 722 participants enrolled in the United States. It is active but not recruiting.
Yes. TP-05 is also referred to as TP-05 (lotilaner) Low Dose, TP-05 Low Dose, TP-05 (lotilaner oral capsules), TP-05 (lotilaner oral), and the fasted group or Low Dose TP-05. These names all refer to the same Tarsus Pharmaceuticals oral lotilaner candidate in Phase 2 for Lyme disease.