Study of ESBA105 Eye Drops in Healthy Subjects
To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers.
To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase I, Randomized, Vehicle-Controlled, Double-Blind, Mono-Centric, Single and Repeated Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ESBA105 Eye Drops in Healthy Subjects|
- safety and tolerability [ Time Frame: several timepoints ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
ESBA105 is an anti TNF single chain antibody fragment