HealthPhase 1NCT01123772
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
A Phase 1 study testing INO-8875 in people with Health, run by Inotek Pharmaceuticals Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- INO-8875
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2011
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male, or a female with a negative pregnancy test and without childbearing potential
- aged 35 to 65 years
- body weight is ≥50 kg and ≤115 kg
Who cannot join
- Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
- Subject has a central retinal vein occlusion in either eye at any time in the past
- Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
- Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
- Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
- Subject is not able to refrain from use of contact lenses during the Treatment Period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers
The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.
- Conditions
- Health
- Being tested
- INO-8875, Placebo control
- Keywords
- adenosine agonist, eye drop, elderly volunteer, older healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-8875Drug
eye drops for 14 days in one eye
Placebo controlOther
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Vehicle control Receives: Other: Placebo control |
| INO-8875 | Experimental | Active drug Receives: Drug: INO-8875 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotek Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123772
- Sponsor's protocol ID
- IPC-09-2009
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2010
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers
- ClinicalTrials.gov ID
- NCT01123772
- Acronym / sponsor ID
- IPC-09-2009
- Conditions
- Health
- Keywords
- adenosine agonist, eye drop, elderly volunteer, older healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 May 2010 (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.
The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Placebo controlVehicle control |
| INO-8875 | Experimental | Drug: INO-8875Active drug |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male, or a female with a negative pregnancy test and without childbearing potential
- aged 35 to 65 years
- body weight is ≥50 kg and ≤115 kg
Key exclusion criteria (6 listed)
- Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
- Subject has a central retinal vein occlusion in either eye at any time in the past
- Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
- Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
- Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
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 |
|---|---|---|
| INO-8875eye drops for 14 days in one eye | Drug | INO-8875 |
| Placebo controlMatched placebo | Other | Control |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 days
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 30 Apr 2012.
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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 INO-8875 in people with Health, run by Inotek Pharmaceuticals Corporation at 1 site in United States.
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 3 inclusion and 6 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 30 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 14 days). 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 30 Apr 2012.