Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
NCT ID: NCT03383276
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
34 participants
INTERVENTIONAL
2017-12-18
2018-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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IL-1Ra
IL-1Ra
custom eye drop to be applied to the left eye.
Interventions
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IL-1Ra
custom eye drop to be applied to the left eye.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
INDUSTRY
Beijing Tongren Hospital
OTHER
Responsible Party
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Locations
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Beijing TongRen Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Feng Wu
Role: primary
Other Identifiers
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2004L00946
Identifier Type: -
Identifier Source: org_study_id