Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TP-05 (lotilaner) Low Dose, TP-05 Low Dose
TP-05 · 2 trials · 1 indication
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag.
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline hematology laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline general appearance
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of head, ears, nose, and throat
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neck (thyroid)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of respiratory system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of cardiovascular system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of gastrointestinal system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neurological system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of skin
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs (including temperature \[degrees Celsius\], pulse rate \[beats per minute\], respiration rate \[breaths per minute\], and changes in systolic and diastolic blood pressure \[mmHg\])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including temperature \[degrees Celsius\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including pulse rate \[beats per minute\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including respiration rate \[breaths per minute\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including changes in systolic and diastolic blood pressure \[mmHg\])
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs (including changes in mean ventricular rate \[beats/min\], pulse rate \[msec\], QRS duration \[msec\], QT interval \[msec\], QTcF interval \[msec\])
| Arm | Type | Description |
|---|---|---|
| TP-05, Fasted Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral), fasted |
| TP-05, High-Fat Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral) following a high-fat meal |
| TP-05, Low-Fat Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral) following a low-fat meal |
| TP-05 SAD | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order |
| Placebo SAD | EXPERIMENTAL | Single dose of Placebo |
| TP-05 MAD | EXPERIMENTAL | Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order |
| Placebo MAD | EXPERIMENTAL | Four doses of Placebo |
| TP-05 Fasted | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral capsules) in a fasted state |
| Placebo Fasted | EXPERIMENTAL | Single dose of placebo in a fasted state |
| Name | Type | Description |
|---|---|---|
| TP-05 (lotilaner oral), fasted group | DRUG | TP-05 (lotilaner oral), fasted group |
| TP-05 (lotilaner oral), high-fat group | DRUG | TP-05 (lotilaner oral), high-fat group |
| TP-05 (lotilaner oral), low-fat group | DRUG | TP-05 (lotilaner oral), low-fat group |
| TP-05 (lotilaner oral capsules) | DRUG | TP-05 (lotilaner oral capsules) |
| Placebo | DRUG | Placebo to match TP-05 (lotilaner oral capsules) |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination * Participants who are non- or ex-smokers * No clinically significant disease captuired in medical history or evidence of clinically significant findings...
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.