Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution

Completed · Phase 1 · Has a placebo group

Conditions studied: Ocular Hypertension, Primary Open Angle Glaucoma

In brief

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.

Key facts

Study ID
NCT04284514
Run by
Aerpio Therapeutics
People needed
91
Starts
2019-05-02
Expected to finish
2019-12-15
Last updated by the study team
2020-02-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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