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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2018
CompletedDecember 26, 2017
December 1, 2017
3 months
December 19, 2017
December 22, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.
3 days
Study Arms (1)
IL-1Ra
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing TongRen Hospital
Beijing, 100730, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
December 26, 2017
Study Start
December 18, 2017
Primary Completion
March 25, 2018
Study Completion
June 10, 2018
Last Updated
December 26, 2017
Record last verified: 2017-12