Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

Overview

The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.

Full Title of Study: “Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2011

Interventions

  • Drug: INO-8875
    • eye drops for 14 days in one eye
  • Other: Placebo control
    • Matched placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Vehicle control
  • Experimental: INO-8875
    • Active drug

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 14 days

Participating in This Clinical Trial

Inclusion Criteria

  • male, or a female with a negative pregnancy test and without childbearing potential – aged 35 to 65 years – body weight is ≥50 kg and ≤115 kg Exclusion Criteria:

  • Subject has glaucoma or any active ophthalmologic disease including conjunctivitis – Subject has a central retinal vein occlusion in either eye at any time in the past – Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine – Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit) – Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil. – Subject is not able to refrain from use of contact lenses during the Treatment Period

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inotek Pharmaceuticals Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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