This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human skin.
The study will consist of a screening period of no more than 30 days. Participants will come to the study center on Day -1 for tick placements on the skin. Nymphal ticks that have been tested negative for human pathogens and are known to be ready to attach will be placed. On Day 1, the number of attached, live ticks will be counted. Participants will be randomized on Day 1 to receive either low dose or high dose of TP-05 or placebo. Tick attachment and mortality will be completed on Day 1 and after participants' return to the study center on Day 2 (24 hours after dosing). Participants will have ticks removed from the skin at the study center after the Day 2 (24 hours) tick count. Participants will come to the study center on Day 30 for another placement of ticks on the skin. Tick attachment and mortality will be determined on Day 30 and on Day 31 (24 hours after placement). Participants will complete the treatment period at Day 60. Participants will undergo a long-term safety follow-up period which will include additional safety and PK visits through Day 301.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
30
Healthy Volunteers will receive a single low dose of TP-05 on Day 1.
Healthy Volunteers will receive a single high dose of TP-05 on Day 1.
Healthy Volunteers will receive a single dose of placebo on Day 1.
Tufts University School of Medicine
Boston, Massachusetts, United States
The Incidence of treatment emergent adverse events from baseline
Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline chemistry laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline hematology laboratory tests
Number of participants with clinically significant changes in clinical laboratory tests
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline vital signs
Number of participants with clinically significant changes in vital signs.
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline electrocardiograms (ECGs)
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\]
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline electrocardiograms (ECGs) measures
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\]
Time frame: Day -1 through Day 301
Clinically significant changes from Baseline QTC interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval
Time frame: Day -1 through Day 301
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Clinically significant changes from Baseline QRS interval
Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval
Time frame: Day -1 through Day 301
Evaluate the concentration of lotilaner in whole blood
Measure of concentration of lotilaner in whole blood at specified timepoints
Time frame: Day -1 through Day 301
TP-05 on Tick Mortality
Evaluate Tick Mortality after TP-05 administration.
Time frame: Day 2 through Day 31