Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07562087 | A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure | PHASE2 | RECRUITING | 700 | — | — | Mar 9, 2026 | Dec 1, 2027 | May 20, 2026 | 19 | United States |
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: ...