NCT03383276

UnknownPhase 1

Phase 1 Study for Safety and Tolerability of IL-1-Ra Topical...

Beijing Tongren Hospital Source

Compare

Other study identifiers

Sponsor study identifier

2004L00946

Study Type

interventional

Estimated enrollment

34

Locations

1 country

Sites

1

Timeline

Study Start

December 18, 2017

Actual (reported)

Primary Completion

March 25, 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 10, 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 34 participants
Study completion date: June 10, 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 18, 2017
Actual (reported)
First Submitted
December 19, 2017
Actual (reported)
First Posted
December 26, 2017
Actual (reported)
Primary Completion
March 25, 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 10, 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 26, 2017
Status Verified: December 2017
Last Update Submitted: December 22, 2017

Conditions

Blepharokeratoconjunctivitis

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

EXPERIMENTAL

Drug: IL-1Ra

Interventions

IL-1RaDrug

custom eye drop to be applied to the left eye.

IL-1Ra

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adult males and/or females between the ages of 18 and 45 years
Medically healthy

Sponsors & Collaborators

Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
Industrycollaborator
Beijing Tongren Hospital
Otherlead

Study Sites (1)

Beijing TongRen Hospital

Beijing, 100730, China

RECRUITING

Feng WuCONTACT0086-010-58268486 trdrug@126.com

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Central Study Contacts

Xiuli Zhao

CONTACT

0086-010-58268486 lilyzhao1028@aliyun.com

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

Actual (reported)

Primary Completion

March 25, 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Study Completion

June 10, 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 26, 2017

Record last verified: 2017-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03383276
Data provider: ClinicalTrials.gov
Source updated: 2017-12-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:37 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (1)

Study Arms (1)

IL-1Ra

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations