Status:
UNKNOWN
Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
Conditions:
Blepharokeratoconjunctivitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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-Re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03383276
Start Date
December 18 2017
End Date
June 10 2018
Last Update
December 26 2017
Active Locations (1)
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1
Beijing TongRen Hospital
Beijing, China, 100730