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

Beijing Tongren Hospital1 site in 1 country34 target enrollmentDecember 18, 2017

ConditionsBlepharokeratoconjunctivitis

InterventionsIL-1Ra

DrugsIL-1Ra

Overview

Phase: Phase 1
Intervention: IL-1Ra
Conditions: Blepharokeratoconjunctivitis
Sponsor: Beijing Tongren Hospital
Enrollment: 34
Locations: 1
Primary Endpoint: Measurement of intraocularpressure
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 18, 2017

End Date

June 10, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Beijing Tongren Hospital

Responsible Party

Sponsor

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