Clinical trial NCT04284514: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Primary Open Angle Glaucoma
Lead sponsor: Aerpio Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Baseline to Day 7
measure: Vital sign- systolic and diastolic blood pressure
timeFrame: Baseline to Day 7
measure: Complete blood count
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: Intraocular pressure
timeFrame: Baseline to Day 7
measure: AKB-9778 concentration
timeFrame: Baseline to Day 7
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
city: Dallas
country: United States
facility: Covance Clinical Research Unit
state: Texas
Study officials:
References: