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Also known as TP-05 (lotilaner) Low Dose
TP-05 Low Dose · 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 small molecule being studied for the prevention of Lyme disease. It is being evaluated in healthy participants with tick exposure, with the goal of killing ticks before they can transmit the bacteria that cause Lyme disease.
TP-05 targets GABA-Cl channels, which are found in ticks and other arthropods. By acting on these channels, TP-05 is designed to kill ticks that attach to a person, potentially preventing the transmission of Lyme disease.
TP-05 is being developed by Tarsus Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker TARS. The company is conducting clinical trials to evaluate the safety and efficacy of TP-05 in healthy participants.
TP-05 is in Phase 1 clinical development. It has completed Phase 1 studies and is also being evaluated in Phase 2 trials, including a study in healthy participants with tick exposure. TP-05 is investigational and has not been approved by the FDA.
TP-05 has been studied in several clinical trials, including NCT07562087, a Phase 2 study in healthy participants with tick exposure, and NCT05720364, a Phase 1 food effect study. Other completed trials include NCT05387083 and NCT05138796, which evaluated safety, tolerability, and pharmacokinetics.
Yes, TP-05 is also known as TP-05 (lotilaner) Low Dose and TP-05 Low Dose. These names refer to the same investigational drug, which is being studied for the prevention of Lyme disease.