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

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Blepharokeratoconjunctivitis

Treatments: Drug: IL-1Ra

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03383276

2004L00946

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 1 patient group

IL-1Ra

Experimental group

Treatment:

Drug: IL-1Ra