A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00414999|
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : July 30, 2007
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 or disease||Intervention/treatment||Phase|
|Macular Degeneration Diabetic Retinopathy||Drug: TG100801||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||February 2007|
- 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.
- Systemic pharmacokinetics (Part B only)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414999
|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.|