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

NCT ID: NCT01748578

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EBI-005-1 5mg/mL

Healthy subjects will be randomized to EBI-005 5mg/mL vs. EBI-005-1 Placebo 3x/day

Group Type: ACTIVE_COMPARATOR

EBI-005-1

Intervention Type: DRUG

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

EBI-005-1 Placebo

Intervention Type: DRUG

EBI-005-1 20 mg/mL

Healthy subjects will be randomized to EBI-005 20 mg/mL vs. EBI-005-1 Placebo 3x/day

Group Type: ACTIVE_COMPARATOR

EBI-005-1

Intervention Type: DRUG

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

EBI-005-1 Placebo

Intervention Type: DRUG

Interventions

EBI-005-1

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

Intervention Type: DRUG

EBI-005-1 Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult males and/or females between the ages of 18 and 65 years
• Medically healthy
• Best correction vision of greater than or equal to 20/40 in each eye
• Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to dosing
• Tolerate topical administration to eye
• Signed and dated, Institutional Review Board (IRB) approved informed consent form (ICF) prior to any protocol-specific screening procedures

Exclusion Criteria

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic (including sensitive skin on the face), neurological, or psychiatric disease, or any other clinically significant disease not deemed acceptable by the PI
• History of any primary malignancy, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
• Occurrence of active seasonal allergies including ocular allergies (e.g.; annual hay fever)
• Abnormalities following ophthalmological examination: abnormality of the cornea, evidence of ocular inflammation (dry eyes, blepharitis, allergic conjunctivitis, iritis, and uveitis), glaucoma, and optic neuropathy
• Subjects with a history of laser refractive surgery (laser assisted stromal in-situ keratomileusis [LASIK], photorefractive keratectomy [PRK]), radial keratotomy (RK), corneal transplantation, dry eyes, or radiotherapy to the eyes
• Use of contact lenses currently or within the past one year
• Positive urine drug/alcohol or cotinine testing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eleven Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Goldstein, MD

Role: STUDY_DIRECTOR

Eleven Biotherapeutics

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

EBI-005-1

Identifier Type: -

Identifier Source: org_study_id