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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eleven Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01748578
First received: December 7, 2012
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Dry Eye
Drug: EBI-005-1
Drug: EBI-005-1 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Eleven Biotherapeutics:

Primary Outcome Measures:
  • Changes from baseline in ocular safety measurements. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Determined by best corrected visual acuity, slit lamp examination, measurement of intraocularpressure (IOP)


Secondary Outcome Measures:
  • ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of EBI-005 in healthy volunteers. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • ELISA based assay to determine Immunogenicity for the evaluation of systemic exposure of EBI-005 in healthy volunteers. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EBI-005-1 5mg/mL
Healthy subjects will be randomized to EBI-005 5mg/mL vs. EBI-005-1 Placebo 3x/day
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
Active Comparator: EBI-005-1 20 mg/mL
Healthy subjects will be randomized to EBI-005 20 mg/mL vs. EBI-005-1 Placebo 3x/day
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748578

Locations
United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Eleven Biotherapeutics
Investigators
Study Director: Michael Goldstein, MD Eleven Biotherapeutics
  More Information

No publications provided

Responsible Party: Eleven Biotherapeutics
ClinicalTrials.gov Identifier: NCT01748578     History of Changes
Other Study ID Numbers: EBI-005-1
Study First Received: December 7, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eleven Biotherapeutics:
Healthy
Interleukin 1 Receptor Inhibitor
Dry Eye

ClinicalTrials.gov processed this record on September 18, 2014