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

NCT01748578 | Completed Phase 1

• 1 other identifier: EBI-005-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Healthy; Interleukin 1 Receptor Inhibitor; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in ocular safety measurements.

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

  1 week

Secondary Outcomes (2)

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

  1 week

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

  1 week

Study Arms (2)

EBI-005-1 5mg/mL

ACTIVE COMPARATOR

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

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

EBI-005-1 20 mg/mL

ACTIVE COMPARATOR

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

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

Interventions

EBI-005-1 DRUG

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

EBI-005-1 20 mg/mL; EBI-005-1 5mg/mL

EBI-005-1 Placebo DRUG

EBI-005-1 20 mg/mL; EBI-005-1 5mg/mL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleven Biotherapeutics: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michael Goldstein, MD

  Eleven Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

US (1)