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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284514
• Other study ID #: AKB-9778-CI-OS-1001
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Aerpio Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• AKB-9778 Ophthalmic Solution
AKB-9778 Ophthalmic Solution
• Placebo Ophthalmic Solution
Matched vehicle-control

Locations

Country	Name	City	State
United States	PPD	Austin	Texas
United States	Covance Clinical Research Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aerpio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Baseline to Day 7
Primary	Vital sign- systolic and diastolic blood pressure	Systolic and diastolic blood pressure in mmHg	Baseline to Day 7
Primary	Complete blood count	White blood cells with differential, hemoglobin, hematocrit and platelet count	Baseline to Day 7
Secondary	Intraocular pressure	Intraocular pressure in mmHg	Baseline to Day 7
Secondary	AKB-9778 concentration	Measurement of AKB-9778 in plasma after drug administration	Baseline to Day 7