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

Phase 1

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: AKB-9778 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution

• Registration Number: NCT04284514
• Lead Sponsor: Aerpio Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2019-08-09
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-24
• Last Update Submitted: 2020-02-24
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKB-9778 Ophthalmic Solution	AKB-9778 Ophthalmic Solution	Up to 4 daily dose levels of AKB-9778 Ophthalmic Solution will be evaluated. Doses will be administered in both eyes daily for 7 days.
Vehicle Control Ophthalmic Solution	Placebo Ophthalmic Solution	Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Vital sign- systolic and diastolic blood pressure	Baseline to Day 7	Systolic and diastolic blood pressure in mmHg
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Baseline to Day 7
Complete blood count	Baseline to Day 7	White blood cells with differential, hemoglobin, hematocrit and platelet count

Secondary Outcome Measures

Name	Time	Method
AKB-9778 concentration	Baseline to Day 7	Measurement of AKB-9778 in plasma after drug administration
Intraocular pressure	Baseline to Day 7	Intraocular pressure in mmHg

Trial Locations

Locations (2)

Covance Clinical Research Unit; 🇺🇸 Dallas, Texas, United States

PPD; 🇺🇸 Austin, Texas, United States