NCT01748578

Phase 1 Study for Safety and Tolerability of EBI-005 Topically Administered to Eyes of Healthy Adult Subjects

A Phase 1, Double-Masked, Placebo-Controlled, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of EBI-005 Topically Administered to Eyes of Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eleven Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of EBI-005 will be assessed.

Detailed description

The planned dose levels are 5 mg/mL EBI-005 (Group 1) and 20 mg/mL EBI-005 (Group 2). A total of 8 subjects will be dosed in each group with subjects randomized in a ratio of 6:2, EBI-005:placebo. Treatment administration in Group 2 will proceed following a review of safety data from Group 1. In both groups, subjects randomized to active treatment will receive EBI-005 in the right eye and placebo in the left eye. Subjects randomized to placebo will receive placebo in each eye.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	EBI-005-1	EBI-005-1 is an intervention to two different study arms: 5mg/ml Vs Placebo and 20 mg/ml Vs Placebo
DRUG	EBI-005-1 Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2012-12-12
• Last updated: 2013-05-08

Locations

1 site across 1 country: United States