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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383276
Recruitment Status : Unknown
Verified December 2017 by Beijing Tongren Hospital.
Recruitment status was:  Recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
Information provided by (Responsible Party):
Beijing Tongren Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blepharokeratoconjunctivitis Drug: IL-1Ra Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : March 25, 2018
Estimated Study Completion Date : June 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
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Arm Intervention/treatment
Experimental: IL-1Ra Drug: IL-1Ra
custom eye drop to be applied to the left eye.


Outcome Measures
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Primary Outcome Measures :
  1. Corneal fluorescein staining [ Time Frame: 3 days ]
  2. Best corrected visual acuity [ Time Frame: 3 days ]
  3. Ocular symptomatology [ Time Frame: 3 days ]
  4. Slit lamp examination [ Time Frame: 3 days ]
  5. Measurement of intraocularpressure [ Time Frame: 3 days ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383276


Contacts
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Contact: Xiuli Zhao 0086-010-58268486 lilyzhao1028@aliyun.com

Locations
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China
Beijing TongRen Hospital Recruiting
Beijing, China, 100730
Contact: Feng Wu    0086-010-58268486    trdrug@126.com   
Sponsors and Collaborators
Beijing Tongren Hospital
Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
More Information
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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03383276    
Other Study ID Numbers: 2004L00946
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents