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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

December 7, 2012
May 6, 2013
November 2012
November 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01748578 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • 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 5mg/mL
    Healthy subjects will be randomized to EBI-005 5mg/mL vs. EBI-005-1 Placebo 3x/day
    Interventions:
    • Drug: EBI-005-1
    • 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
    Interventions:
    • Drug: EBI-005-1
    • Drug: EBI-005-1 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01748578
EBI-005-1
No
Eleven Biotherapeutics
Eleven Biotherapeutics
Not Provided
Study Director: Michael Goldstein, MD Eleven Biotherapeutics
Eleven Biotherapeutics
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP