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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)

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EBI-005-1

EBI-005-1 Placebo

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Healthy, Interleukin 1 Receptor Inhibitor, Dry Eye

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

EBI-005-1 5mg/mL

EBI-005-1 20 mg/mL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes from baseline in ocular safety measurements.

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.

ELISA based assay to determine Immunogenicity for the evaluation of systemic exposure of EBI-005 in healthy volunteers.

Full Information

NCT ID

NCT01748578

First Posted

December 7, 2012

Last Updated

May 6, 2013

Sponsor

Eleven Biotherapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01748578

Brief Title

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

Acronym

EBI-005-1

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

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eleven Biotherapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Healthy, Interleukin 1 Receptor Inhibitor, Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EBI-005-1 5mg/mL

Arm Type

Active Comparator

Arm Description

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

Arm Title

EBI-005-1 20 mg/mL

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

EBI-005-1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

EBI-005-1 Placebo

Primary Outcome Measure Information:

Title

Changes from baseline in ocular safety measurements.

Description

Determined by best corrected visual acuity, slit lamp examination, measurement of intraocularpressure (IOP)

Time Frame

1 week

Secondary Outcome Measure Information:

Title

ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of EBI-005 in healthy volunteers.

Time Frame

1 week

Title

ELISA based assay to determine Immunogenicity for the evaluation of systemic exposure of EBI-005 in healthy volunteers.

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Goldstein, MD

Organizational Affiliation

Eleven Biotherapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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