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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05387083 | A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05 | PHASE2 | COMPLETED | 30 | — | — | Dec 12, 2022 | Jun 26, 2024 | Sep 19, 2024 | 1 | 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 |
|---|---|---|
| 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...