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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of ocular administration of Topical Interleukin-1-Receptor Antagonist in healthy volunteers. Additionally, the PK of Interleukin-1-Receptor Antagonist will be assessed.

Official Title
-----------------
A Phase 1, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects

Conditions
-----------------
Blepharokeratoconjunctivitis

Intervention / Treatment
-----------------
* Drug: IL-1Ra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males and/or females between the ages of 18 and 45 years Medically healthy Best correction vision of greater than or equal to 20/20 in each eye BMI ≥ 19 and < 24 kg/m2 Ability to understand and provide informed consent to participate in this study Willingness to follow study instructions and likely to complete all required visits Exclusion Criteria: Any ocular or systemic diseases History of skin or ocular allergy symptoms Use contact lenses during the trails. Taking inhaled or oral steroids (for example Advair, Orapred) Have an active infection Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis Receipt of any blood or blood products within 2 months prior to the first dosing day. Use any drugs within 2 weeks prior to the first dosing day. Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication or experimental drug within the past 4 weeks. Have been exposed to an investigational drug/device within the preceding 3 months Pregnant or lactating females History of substance abuse, drug addiction or alcoholism Males and females unwilling to use an acceptable method of contraception for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IL-1Ra<br> | Drug: IL-1Ra<br>* custom eye drop to be applied to the left eye.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining |  | 3 days | 
| Best corrected visual acuity |  | 3 days | 
| Ocular symptomatology |  | 3 days | 
| Slit lamp examination |  | 3 days | 
| Measurement of intraocularpressure |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers. |  | 3 days |