A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers

July 27, 2007 updated by: TargeGen

A Phase 1, Double-Masked, Placebo-Controlled, Dose-Escalation Study (in Two Parts) of TG100801 and a Colored Vehicle in Adult Healthy Volunteers

The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation contribute to the progression of the eye disease, age-related macular degeneration (AMD), which is the leading cause of irreversible, severe loss of vision in people 55 years of age and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis, vascular leak, and inflammation in laboratory studies, and may have great utility in the treatment of diseases such as AMD.

The purpose of this study is to assess the safety, ocular tolerability, and blood pharmacokinetics of TG100801 at escalating doses in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Quintiles Phase One Services, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female healthy volunteers who meet the following criteria are eligible for inclusion in the study. Subjects who participate in Part A of the study may not participate in Part B.

  • Age > 18 years (50% of subjects must be > 40 years of age).
  • Corrected visual acuity > 20/25 in both eyes.
  • Intraocular pressure (IOP) < 21 mm Hg, with a difference between eyes of < 4 mm Hg.
  • Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff.
  • Tolerance of a commercially available benzalkonium chloride-preserved, artificial tear solution in one eye.
  • Normal slit lamp exam and dilated fundoscopic exam within 2 weeks of dosing.
  • Normal clinical laboratory profiles, defined as complete blood count, serum chemistry, and urinalysis values within the normal range.
  • Willing to abstain from the concomitant use of ocular or systemic medication (excluding acetaminophen and multivitamins) from 2 weeks prior to start of study dosing until study completion.
  • Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
  • Provide written informed consent to participate.

Exclusion Criteria:

Subjects who meet any of the following criteria are excluded from the study:

  • History of ocular surgery, trauma, or chronic ocular disease.
  • Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
  • Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales).
  • Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period.
  • Systemic corticosteroid use within the past 6 months.
  • History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis.
  • Presence of a nonhealing wound, ulcer, fracture, or any medical condition associated with bleeding.
  • Use of antimitotic or antimetabolite therapy within 2 months of enrollment.
  • Loss, donation, or removal of 400 mL or more of blood within the past 2 months.
  • Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use two proven methods of contraception during and for at least 2 weeks following the final dose of study drug.
  • Enrollment in another investigational drug or device study within 2 months of study entry.
  • Ongoing cardiac arrhythmias or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females.
  • Known liver, kidney, cardiovascular, neurologic, or pulmonary disease; treated or untreated hypertension; current or history of drug or alcohol abuse.
  • Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
  • Known intolerance to any excipients in the study drug formulation.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, would affect the subject's ability to follow study-related procedures, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.
Part B: Safety & tolerability of 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 14 days, assessed up to 7-14 days following dosing.

Secondary Outcome Measures

Outcome Measure
Systemic pharmacokinetics (Part B only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TargeGen

Investigators

  • Principal Investigator: Philip T Leese, M.D., Quintiles Phase One Services, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

December 20, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (ESTIMATE)

December 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2007

Last Update Submitted That Met QC Criteria

July 27, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH-TG100801-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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