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

NCT05387083 | Completed Phase 2 FDA Drug

• 1 other identifier: TRS-015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lyme Disease; Ticks

Outcome Measures

Primary Outcomes (8)

• 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.

  Day -1 through Day 301

• Clinically significant changes from Baseline chemistry laboratory tests

  Number of participants with clinically significant changes in clinical laboratory tests

  Day -1 through Day 301

• Clinically significant changes from Baseline hematology laboratory tests

  Number of participants with clinically significant changes in clinical laboratory tests

  Day -1 through Day 301

• Clinically significant changes from Baseline vital signs

  Number of participants with clinically significant changes in vital signs.

  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 \[beats/min\]

  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 \[msec\]

  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

  Day -1 through Day 301

• Clinically significant changes from Baseline QRS interval

  Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval

  Day -1 through Day 301

Secondary Outcomes (2)

• Evaluate the concentration of lotilaner in whole blood

  Day -1 through Day 301

• TP-05 on Tick Mortality

  Day 2 through Day 31

Study Arms (3)

Low Dose of TP-05 (lotilaner)

EXPERIMENTAL

Single Oral Low Dose of TP-05 tablet.

Drug: Low Dose TP-05

High Dose of TP-05 (lotilaner)

EXPERIMENTAL

Single Oral High Dose of TP-05 tablet.

Drug: High Dose TP-05

Placebo

PLACEBO COMPARATOR

Single Oral Dose of placebo tablet.

Drug: Placebo Comparator

Interventions

Low Dose TP-05 DRUG

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

Also known as: Lotilaner

Low Dose of TP-05 (lotilaner)

High Dose TP-05 DRUG

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

Also known as: Lotilaner

High Dose of TP-05 (lotilaner)

Placebo Comparator DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including having no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination.
• Participants who are non- or ex-smokers.
• Willingness to comply with all study procedures and availability for the duration of the study.
• BMI within the range 18 - 32 kg/m2
• Willingness to comply with contraceptive requirements
• Capable of giving signed informed consent

You may not qualify if:

• Female who is lactating at Screening.
• Female who is pregnant according to the serum pregnancy test at Screening or prior to study treatment administration.
• History of significant hypersensitivity to lotilaner or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Presence or history of significant gastrointestinal, metabolic, liver or kidney disease, or surgery that may affect drug bioavailability (excluding appendectomy).
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
• Have a history of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma.
• Presence of clinically significant ECG abnormalities at Screening, as defined by the Investigator.
• Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse.
• Any clinically significant illness in the 28 days prior to study treatment administration.
• Known history of chronic infectious disease.
• History of allergy to surgical tape, hydrocolloid, or dressing.
• History of severe reactions to tick bites (granuloma or systemic reactions).
• Use of any non-prescription or prescription drugs (with the exception of hormonal contraceptives, hormone replacement therapy, acetaminophen) in the 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study treatment administration.
• Use of St. John's wort in the 28 days prior to study treatment administration.
• Intake of lotilaner in the 6 months prior to study treatment administration.

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Lyme Disease

Interventions

lotilaner

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Kavita Dhamdhere, MD, PhD

  Tarsus Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Linden Hu, MD

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yoav Golan

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 24, 2022
• Study Start: December 12, 2022
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)