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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03383276

Enrollment

Registered

2017-12-26

Start date

2017-12-18

Completion date

2018-06-10

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharokeratoconjunctivitis

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.

Interventions

DRUGIL-1Ra

custom eye drop to be applied to the left eye.

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.	3 days

Countries

China

Contacts

Primary ContactXiuli Zhao

lilyzhao1028@aliyun.com0086-010-58268486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026