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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Vehicle Control Ophthalmic Solution | Placebo Comparator | Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-9778 Ophthalmic Solution | Drug | AKB-9778 Ophthalmic Solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Baseline to Day 7 | |
| Vital sign- systolic and diastolic blood pressure | Systolic and diastolic blood pressure in mmHg | Baseline to Day 7 |
| Complete blood count | White blood cells with differential, hemoglobin, hematocrit and platelet count | Baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Intraocular pressure in mmHg | Baseline to Day 7 |
| AKB-9778 concentration | Measurement of AKB-9778 in plasma after drug administration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States | ||
| Covance Clinical Research Unit |
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| Placebo Ophthalmic Solution |
| Drug |
Matched vehicle-control |
|
| Baseline to Day 7 |
| Dallas |
| Texas |
| 75247 |
| United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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