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

Eleven Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Dry Eye

Treatments: Drug: EBI-005-1 Placebo; Drug: EBI-005-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01748578

EBI-005-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

EBI-005-1 5mg/mL

Active Comparator group

Description:

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

Treatment:

Drug: EBI-005-1 Placebo

Drug: EBI-005-1

EBI-005-1 20 mg/mL

Active Comparator group

Description:

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

Treatment:

Drug: EBI-005-1 Placebo

Drug: EBI-005-1