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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04284514

Enrollment

Registered

2020-02-25

Start date

2019-05-02

Completion date

2019-12-15

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open Angle Glaucoma

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.

Interventions

DRUGAKB-9778 Ophthalmic Solution

AKB-9778 Ophthalmic Solution

DRUGPlacebo Ophthalmic Solution

Matched vehicle-control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Intraocular pressure	Baseline to Day 7	Intraocular pressure in mmHg
AKB-9778 concentration	Baseline to Day 7	Measurement of AKB-9778 in plasma after drug administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026