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

Primary Purpose

Ocular Hypertension, Primary Open Angle Glaucoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AKB-9778 Ophthalmic Solution

Placebo Ophthalmic Solution

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

PPD
Covance Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AKB-9778 Ophthalmic Solution

Vehicle Control Ophthalmic Solution

Arm Description

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.

Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Vital sign- systolic and diastolic blood pressure

Systolic and diastolic blood pressure in mmHg

Complete blood count

White blood cells with differential, hemoglobin, hematocrit and platelet count

Secondary Outcome Measures

Intraocular pressure

Intraocular pressure in mmHg

AKB-9778 concentration

Measurement of AKB-9778 in plasma after drug administration

Full Information

NCT ID

NCT04284514

First Posted

August 9, 2019

Last Updated

February 24, 2020

Sponsor

Aerpio Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04284514

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2, 2019 (Actual)

Primary Completion Date

December 15, 2019 (Actual)

Study Completion Date

December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aerpio Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension, Primary Open Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AKB-9778 Ophthalmic Solution

Arm Type

Experimental

Arm Description

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.

Arm Title

Vehicle Control Ophthalmic Solution

Arm Type

Placebo Comparator

Arm Description

Matched vehicle-control ophthalmic solution will be administered in both eyes daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

AKB-9778 Ophthalmic Solution

Intervention Description

AKB-9778 Ophthalmic Solution

Intervention Type

Drug

Intervention Name(s)

Placebo Ophthalmic Solution

Intervention Description

Matched vehicle-control

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Baseline to Day 7

Title

Vital sign- systolic and diastolic blood pressure

Description

Systolic and diastolic blood pressure in mmHg

Time Frame

Baseline to Day 7

Title

Complete blood count

Description

White blood cells with differential, hemoglobin, hematocrit and platelet count

Time Frame

Baseline to Day 7

Secondary Outcome Measure Information:

Title

Intraocular pressure

Description

Intraocular pressure in mmHg

Time Frame

Baseline to Day 7

Title

AKB-9778 concentration

Description

Measurement of AKB-9778 in plasma after drug administration

Time Frame

Baseline to Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

PPD

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

Facility Name

Covance Clinical Research Unit

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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