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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
91
AKB-9778 Ophthalmic Solution
Matched vehicle-control
PPD
Austin, Texas, United States
Covance Clinical Research Unit
Dallas, Texas, United States
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
Systolic and diastolic blood pressure in mmHg
Time frame: Baseline to Day 7
Complete blood count
White blood cells with differential, hemoglobin, hematocrit and platelet count
Time frame: Baseline to Day 7
Intraocular pressure
Intraocular pressure in mmHg
Time frame: Baseline to Day 7
AKB-9778 concentration
Measurement of AKB-9778 in plasma after drug administration
Time frame: Baseline to Day 7
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