BlepharokeratoconjunctivitisPhase 1NCT03383276
Phase 1 Study for Safety and Tolerability of IL-1-Ra Topically Administered to Eyes of Healthy Adult Subjects
A Phase 1 study testing IL-1Ra in people with Blepharokeratoconjunctivitis, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blepharokeratoconjunctivitis
- What is being tested?
- IL-1Ra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2017to 10 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing TongRen Hospital
Beijing, 100730
Feng Wu, 0086-010-58268486, trdrug@126.com
About this study
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
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.
- Conditions
- Blepharokeratoconjunctivitis
- Being tested
- IL-1Ra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-1RaDrug
custom eye drop to be applied to the left eye.
| Study group | Role | What they receive |
|---|---|---|
| IL-1Ra | Experimental | Not described Receives: Drug: IL-1Ra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining
Measured: 3 days
Best corrected visual acuity
Measured: 3 days
Ocular symptomatology
Measured: 3 days
Slit lamp examination
Measured: 3 days
Measurement of intraocularpressure
Measured: 3 days
Secondary outcomes (1)
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start18 Dec 2017
- Primary completion25 Mar 2018 (estimated)
- Study completion10 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharokeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383276
- Sponsor's protocol ID
- 2004L00946
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03383276
- Acronym / sponsor ID
- 2004L00946
- Conditions
- Blepharokeratoconjunctivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Chengdu Rhodiola Bio-Pharmaceutical Co Ltd
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 25 Mar 2018 (estimated)
- Study completion
- 10 Jun 2018 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IL-1Ra | Experimental | Drug: IL-1Ra |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-1Racustom eye drop to be applied to the left eye. | Drug | IL-1Ra |
Primary outcome
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
1 secondary outcome
ELISA based assay to determine Pharmacokinetics for the evaluation of systemic exposure of IL-1Ra in healthy volunteers.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IL-1Ra in people with Blepharokeratoconjunctivitis, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zhao (0086-010-58268486, lilyzhao1028@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal fluorescein staining (time frame: 3 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.