NCT04284514

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Aerpio Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ocular Hypertension
• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	AKB-9778 Ophthalmic Solution	AKB-9778 Ophthalmic Solution
DRUG	Placebo Ophthalmic Solution	Matched vehicle-control

Timeline

• Start date: 2019-05-02
• Primary completion: 2019-12-15
• Completion: 2019-12-15
• First posted: 2020-02-25
• Last updated: 2020-02-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study