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Sponsored by: |
TargeGen |
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Information provided by: | TargeGen |
ClinicalTrials.gov Identifier: | NCT00414999 |
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.
Condition | Intervention | Phase |
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Macular Degeneration Diabetic Retinopathy |
Drug: TG100801 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 1, Double-Masked, Placebo-Controlled, Dose-Escalation Study (in Two Parts) of TG100801 and a Colored Vehicle in Adult Healthy Volunteers |
Enrollment: | 44 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Exclusion Criteria:
Subjects who meet any of the following criteria are excluded from the study:
United States, Kansas | |
Quintiles Phase One Services, Inc. | |
Lenexa, Kansas, United States, 66219 |
Principal Investigator: | Philip T Leese, M.D. | Quintiles Phase One Services, Inc. |
Study ID Numbers: | OPH-TG100801-001 |
Study First Received: | December 20, 2006 |
Last Updated: | July 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00414999 |
Health Authority: | United States: Food and Drug Administration |
Macular degeneration Vascular diseases Retinal disorders Macular edema |
Eye Diseases Vascular Diseases Diabetes Mellitus Macular Degeneration Edema Endocrine System Diseases Retinal Degeneration Tetrahydrozoline |
Healthy Diabetic Angiopathies Macular Edema Diabetic Retinopathy Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
Cardiovascular Diseases |