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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

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date December 26, 2017
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date March 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Corneal fluorescein staining [ Time Frame: 3 days ]
  • Best corrected visual acuity [ Time Frame: 3 days ]
  • Ocular symptomatology [ Time Frame: 3 days ]
  • Slit lamp examination [ Time Frame: 3 days ]
  • Measurement of intraocularpressure [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers. [ Time Frame: 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Dose Escalating Study of the Safety, Tolerability, and Pharmacokinetics of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blepharokeratoconjunctivitis
Intervention  ICMJE Drug: IL-1Ra
custom eye drop to be applied to the left eye.
Study Arms  ICMJE Experimental: IL-1Ra
Intervention: Drug: IL-1Ra
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 10, 2018
Estimated Primary Completion Date March 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03383276
Other Study ID Numbers  ICMJE 2004L00946
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Tongren Hospital
Study Sponsor  ICMJE Beijing Tongren Hospital
Collaborators  ICMJE Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
Investigators  ICMJE Not Provided
PRS Account Beijing Tongren Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP