Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution
Status:
Completed
Trial end date:
2019-12-15
Target enrollment:
Participant gender:
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. 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.