Clinical trial NCT01748578: Phase 1 Study for Safety and Tolerability of EBI-005 Topically Administered to Eyes of Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye
Keywords: Healthy
Interleukin 1 Receptor Inhibitor
Dry Eye
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline in ocular safety measurements.
timeFrame: 1 week
Secondary outcomes:
measure: ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of EBI-005 in healthy volunteers.
timeFrame: 1 week
measure: ELISA based assay to determine Immunogenicity for the evaluation of systemic exposure of EBI-005 in healthy volunteers.
timeFrame: 1 week
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Eleven Biotherapeutics
name: Michael Goldstein, MD
role: STUDY_DIRECTOR
References: