A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers
NCT00414999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2007-07-30
Summary
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.
Conditions
- Macular Degeneration
- Diabetic Retinopathy
Interventions
- DRUG
-
TG100801
Sponsors & Collaborators
-
TargeGen
lead INDUSTRY
Principal Investigators
-
Philip T Leese, M.D. · Quintiles Phase One Services, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-11-30
- Completion
- 2007-02-28
Countries
- United States
Study Locations
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