Overview

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

Status:
Completed
Trial end date:
2019-12-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Aerpio Therapeutics
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Key Inclusion Criteria:

- Aged > 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in
Cohorts 2-4, aged 18 to 80 years inclusive in Cohort 5.

- For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in
Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP
between 17 and 27 mm Hg (inclusive).

- Central corneal thickness of 480 to 600 μm, inclusive

- For subjects in Cohort 5, diagnosis of OAG or OHT

- For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering

Key Exclusion Criteria:

- Diagnosis of any form of glaucoma in Cohorts 1-4

- Clinically significant eye trauma within 6 months of screening

- Any intraocular ophthalmic procedure within 6 months of screening

- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis
in either eye

- Subjects with any known chronic ocular disease (other than incipient cataract or
refractive error)

- Any condition preventing valid applanation tonometry measurement, e.g., clinically
significant corneal disease, refractive surgery

- Visual acuity (VA) worse than 20/30 in either eye, For Cohort 5 VA worse than 20/100
in either eye