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

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

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.

Study Overview

• Status: Unknown
• Conditions: Blepharokeratoconjunctivitis
• Intervention / Treatment: Drug: IL-1Ra

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiuli Zhao; Phone Number: 0086-010-58268486; Email: lilyzhao1028@aliyun.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Beijing Tongren Hospital
    • Contact: Feng Wu; Phone Number: 0086-010-58268486; Email: trdrug@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IL-1Ra	Drug: IL-1Ra; custom eye drop to be applied to the left eye.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Chengdu Rhodiola Bio-Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): March 25, 2018
• Study Completion (Anticipated): June 10, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: 2004L00946

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No