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A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects

NCT05138861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-12

No results posted yet for this study

Summary

Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.

Conditions

  • Healthy

Interventions

DRUG

TP-03 (Lotilaner Ophthalmic Solution), 0.25%

A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye.

Sponsors & Collaborators

  • Tarsus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Holdbrook · Tarsus Pharmaceuticals

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2021-09-03
Completion
2021-09-03
FDA Drug
Yes

Countries

  • Canada

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 NCT05138861 on ClinicalTrials.gov