HealthyPhase 1NCT00671619
Study of ESBA105 Eye Drops in Healthy Subjects
A Phase 1 study testing ESBA105 in people with Healthy, run by ESBATech AG at 1 site in Switzerland.
Trial summary
Objectives: To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers. To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ESBA105
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Aug 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female Caucasian subjects.
- Written informed consent prior to any study procedures including screening tests for eligibility.
- Subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Normal sitting blood pressure and pulse rate, i.e.: BP: 100-160 mm Hg systolic, 50-90 mm Hg diastolic and pulse rate: 45-100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
- Bilateral corrected visual acuity of at least 0.9
- No need for regular concomitant medication.
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
- Use of qualified contraception
Who cannot join
- Any evidence of infectious disease as evidenced by medical history, clinical examination, positive serology results which indicate the presence of hepatitis B and/ or C or HIV infection or positive results of the QuantiFERON TB Gold test based latent tuberculosis testing.
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy including allergic conjunctivitis requiring acute or chronic treatment (seasonal allergic rhinitis not associated to conjunctivitis which requires no treatment may be tolerated).
- Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
- Existence of any surgical or medical condition which might interfere with the evaluation of the general drug safety and tolerability including clinically relevant ophthalmological diseases, impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, haematological abnormalities, psychiatric diseases, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
- Shallow anterior chamber, closed angle glaucoma or any other contraindication to eye dilation for ophthalmological examination.
- History or presence of any other clinically relevant (in the opinion of the Investigator) ocular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Vehicle-Controlled, Double-Blind, Mono-Centric, Single and Repeated Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ESBA105 Eye Drops in Healthy Subjects
Objectives:
To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers.
To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers.
Read the detailed description
ESBA105 is an anti TNF single chain antibody fragment
- Conditions
- Healthy
- Being tested
- ESBA105
- Keywords
- opthalmology, antibody fragment, TNF alpha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBA105Drug
eye drops
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Measured: several timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESBATech AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671619
- Sponsor's protocol ID
- ESBA105CRD01
- Status last verified
- Aug 2008
- First submitted
- 28 Apr 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Vehicle-Controlled, Double-Blind, Mono-Centric, Single and Repeated Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ESBA105 Eye Drops in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00671619
- Acronym / sponsor ID
- ESBA105CRD01
- Conditions
- Healthy
- Keywords
- opthalmology, antibody fragment, TNF alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ESBATech AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 May 2008 (estimated)
- 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.
Objectives:
To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically to the eye for up to 28 days in healthy volunteers.
To determine the systemic exposure to ESBA105 upon single and repeated-dose topical application to the eye in healthy volunteers.
Detailed description
ESBA105 is an anti TNF single chain antibody fragment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female Caucasian subjects.
- Written informed consent prior to any study procedures including screening tests for eligibility.
- Subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Normal sitting blood pressure and pulse rate, i.e.: BP: 100-160 mm Hg systolic, 50-90 mm Hg diastolic and pulse rate: 45-100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
- Bilateral corrected visual acuity of at least 0.9
Key exclusion criteria (7 listed)
- Any evidence of infectious disease as evidenced by medical history, clinical examination, positive serology results which indicate the presence of hepatitis B and/ or C or HIV infection or positive results of the QuantiFERON TB Gold test based latent tuberculosis testing.
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy including allergic conjunctivitis requiring acute or chronic treatment (seasonal allergic rhinitis not associated to conjunctivitis which requires no treatment may be tolerated).
- Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
- Existence of any surgical or medical condition which might interfere with the evaluation of the general drug safety and tolerability including clinically relevant ophthalmological diseases, impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, haematological abnormalities, psychiatric diseases, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
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 |
|---|---|---|
| ESBA105eye drops | Drug | – |
Primary outcome
safety and tolerability
Time frame: several timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ESBA105 in people with Healthy, run by ESBATech AG at 1 site in Switzerland.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 25 Aug 2008. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: several timepoints). 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 25 Aug 2008.