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

Phase 1

• Conditions: Blepharokeratoconjunctivitis
• Interventions: Drug: IL-1Ra

• Registration Number: NCT03383276
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-18
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26
• Primary Completion: 2018-03-25
• Study Completion: 2018-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IL-1Ra	IL-1Ra	-

Primary Outcome Measures

Name	Time	Method
Corneal fluorescein staining	3 days
Best corrected visual acuity	3 days
Ocular symptomatology	3 days
Measurement of intraocularpressure	3 days
Slit lamp examination	3 days

Secondary Outcome Measures

Name	Time	Method
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.	3 days

Trial Locations

Locations (1)

Beijing TongRen Hospital; 🇨🇳 Beijing, China