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A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05

NCT05387083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Low Dose TP-05

Healthy Volunteers will receive a single low dose of TP-05 on Day 1.

DRUG

High Dose TP-05

Healthy Volunteers will receive a single high dose of TP-05 on Day 1.

DRUG

Placebo Comparator

Healthy Volunteers will receive a single dose of placebo on Day 1.

Sponsors & Collaborators

  • Tarsus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Kavita Dhamdhere, MD, PhD · Tarsus Pharmaceuticals, Inc.

  • Linden Hu, MD · Tufts University School of Medicine

  • Yoav Golan · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-06-26
Completion
2024-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387083 on ClinicalTrials.gov