Ocular HypertensionPhase 1NCT04284514
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution
A Phase 1 study testing AKB-9778 Ophthalmic Solution in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Aerpio Therapeutics at 2 sites in United States.
Trial summary
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The study is a double-masked, multiple- ascending dose trial and will enroll four cohorts of up to 12 subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma
- What is being tested?
- AKB-9778 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2019to 15 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged > 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in Cohorts 2-4, aged 18 to 80 years inclusive in Cohort 5.
- For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP between 17 and 27 mm Hg (inclusive).
- Central corneal thickness of 480 to 600 μm, inclusive
- For subjects in Cohort 5, diagnosis of OAG or OHT
- For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering
Who cannot join
- Diagnosis of any form of glaucoma in Cohorts 1-4
- Clinically significant eye trauma within 6 months of screening
- Any intraocular ophthalmic procedure within 6 months of screening
- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye
- Subjects with any known chronic ocular disease (other than incipient cataract or refractive error)
- Any condition preventing valid applanation tonometry measurement, e.g., clinically significant corneal disease, refractive surgery
- Visual acuity (VA) worse than 20/30 in either eye, For Cohort 5 VA worse than 20/100 in either eye
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD
Austin, Texas, 78744
Covance Clinical Research Unit
Dallas, Texas, 75247
About this study
Official title: Phase 1 Multi Center, Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The study is a double-masked, multiple- ascending dose trial and will enroll four cohorts of up to 12 subjects. Dose cohorts will receive increasing doses of AKB-9778 ophthalmic solution or vehicle-matched placebo daily for 7 days. Cohort 5 will enroll subjects with open angle glaucoma or ocular hypertension who will continue current prostaglandin therapy during the study. Cohort 5 subjects will receive the maximum tolerated dose from the previous cohorts.
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Being tested
- AKB-9778 Ophthalmic Solution, Placebo Ophthalmic Solution
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-9778 Ophthalmic SolutionDrug
AKB-9778 Ophthalmic Solution
Placebo Ophthalmic SolutionDrug
Matched vehicle-control
| Study group | Role | What they receive |
|---|---|---|
| AKB-9778 Ophthalmic Solution | Experimental | Up to 4 daily dose levels of AKB-9778 Ophthalmic Solution will be evaluated. Doses will be administered in both eyes daily for 7 days. Receives: Drug: AKB-9778 Ophthalmic Solution |
| Vehicle Control Ophthalmic Solution | Placebo comparator | Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days. Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Baseline to Day 7
Vital sign- systolic and diastolic blood pressure
Systolic and diastolic blood pressure in mmHg
Measured: Baseline to Day 7
Complete blood count
White blood cells with differential, hemoglobin, hematocrit and platelet count
Measured: Baseline to Day 7
Secondary outcomes (2)
Intraocular pressure
Intraocular pressure in mmHg
Measured: Baseline to Day 7
AKB-9778 concentration
Measurement of AKB-9778 in plasma after drug administration
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start2 May 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerpio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284514
- Sponsor's protocol ID
- AKB-9778-CI-OS-1001
- Status last verified
- Feb 2020
- First submitted
- 9 Aug 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multi Center, Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution
- ClinicalTrials.gov ID
- NCT04284514
- Acronym / sponsor ID
- AKB-9778-CI-OS-1001
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Aerpio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 25 Feb 2020 (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 Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The study is a double-masked, multiple- ascending dose trial and will enroll four cohorts of up to 12 subjects. Dose cohorts will receive increasing doses of AKB-9778 ophthalmic solution or vehicle-matched placebo daily for 7 days. Cohort 5 will enroll subjects with open angle glaucoma or ocular hypertension who will continue current prostaglandin therapy during the study. Cohort 5 subjects will receive the maximum tolerated dose from the previous cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKB-9778 Ophthalmic Solution | Experimental | Drug: AKB-9778 Ophthalmic SolutionUp to 4 daily dose levels of AKB-9778 Ophthalmic Solution will be evaluated. Doses will be administered in both eyes daily for 7 days. |
| Vehicle Control Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic SolutionMatched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged > 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in Cohorts 2-4, aged 18 to 80 years inclusive in Cohort 5.
- For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP between 17 and 27 mm Hg (inclusive).
- Central corneal thickness of 480 to 600 μm, inclusive
- For subjects in Cohort 5, diagnosis of OAG or OHT
- For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering
Key exclusion criteria (7 listed)
- Diagnosis of any form of glaucoma in Cohorts 1-4
- Clinically significant eye trauma within 6 months of screening
- Any intraocular ophthalmic procedure within 6 months of screening
- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye
- Subjects with any known chronic ocular disease (other than incipient cataract or refractive error)
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 |
|---|---|---|
| AKB-9778 Ophthalmic SolutionAKB-9778 Ophthalmic Solution | Drug | AKB-9778 Ophthalmic Solution |
| Placebo Ophthalmic SolutionMatched vehicle-control | Drug | Vehicle Control Ophthalmic Solution |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Baseline to Day 7
Vital sign- systolic and diastolic blood pressure
Time frame: Baseline to Day 7
Systolic and diastolic blood pressure in mmHg
Complete blood count
Time frame: Baseline to Day 7
White blood cells with differential, hemoglobin, hematocrit and platelet count
2 secondary outcomes
Intraocular pressure
Time frame: Baseline to Day 7
AKB-9778 concentration
Time frame: Baseline to Day 7
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 Feb 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AKB-9778 Ophthalmic Solution in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Aerpio Therapeutics at 2 sites 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 5 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Baseline to Day 7). The study lists 3 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 25 Feb 2020.