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Also known as TP-05 (lotilaner) Low Dose, TP-05 Low Dose
Low Dose 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 |
|---|---|---|
| Low Dose of TP-05 (lotilaner) | EXPERIMENTAL | Single Oral Low Dose of TP-05 tablet. |
| High Dose of TP-05 (lotilaner) | EXPERIMENTAL | Single Oral High Dose of TP-05 tablet. |
| Placebo | PLACEBO_COMPARATOR | Single Oral Dose of placebo tablet. |
| Name | Type | Description |
|---|---|---|
| Low Dose TP-05 | DRUG | Healthy Volunteers will receive a single low dose of TP-05 on Day 1. |
| High Dose TP-05 | DRUG | Healthy Volunteers will receive a single high dose of TP-05 on Day 1. |
| Placebo Comparator | DRUG | Healthy Volunteers will receive a single dose of placebo on Day 1. |
Inclusion Criteria: 1. Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical evaluation including having no clinically significant diseases captured in the medical history or evidence of cli...
Low Dose TP-05 is an investigational small molecule being studied for the prevention of Lyme disease in healthy volunteers with tick exposure. It is currently in Phase 2 clinical development and is not approved by the FDA.
Low Dose TP-05 contains lotilaner, a small molecule that targets and inhibits insect and acarine GABA-gated chloride channels. This mechanism is intended to kill ticks before they can transmit Borrelia burgdorferi, the bacterium that causes Lyme disease.
Low Dose TP-05 is being developed by Tarsus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker TARS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in preventing Lyme disease.
Low Dose TP-05 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The most advanced trial is a Phase 2 study in healthy participants with tick exposure, which is active but not recruiting.
Low Dose TP-05 has been studied in four clinical trials. NCT05720364 and NCT05138796 are completed Phase 1 pharmacokinetic studies in healthy subjects. NCT05387083 is a completed Phase 2 human tick kill study. NCT07562087 is an active Phase 2 efficacy trial in healthy participants with tick exposure.
Yes, Low Dose TP-05 is a formulation of TP-05, which contains the active ingredient lotilaner. It is also referred to as TP-05 (lotilaner) Low Dose or TP-05 Low Dose. All these names refer to the same investigational drug being developed by Tarsus Pharmaceuticals.