NCT04284514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

August 9, 2019

Last Update Submit

February 24, 2020

Conditions

Ocular HypertensionPrimary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (3)

  • 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

    Systolic and diastolic blood pressure in mmHg

    Baseline to Day 7

  • Complete blood count

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

    Baseline to Day 7

Secondary Outcomes (2)

  • Intraocular pressure

    Baseline to Day 7

  • AKB-9778 concentration

    Baseline to Day 7

Study Arms (2)

AKB-9778 Ophthalmic Solution

EXPERIMENTAL

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.

Drug: AKB-9778 Ophthalmic Solution

Vehicle Control Ophthalmic Solution

PLACEBO COMPARATOR

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

Drug: Placebo Ophthalmic Solution

Interventions

AKB-9778 Ophthalmic SolutionDRUG

AKB-9778 Ophthalmic Solution

AKB-9778 Ophthalmic Solution
Placebo Ophthalmic SolutionDRUG

Matched vehicle-control

Vehicle Control Ophthalmic Solution

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PPD

Austin, Texas, 78744, United States

Location

Covance Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

February 25, 2020

Study Start

May 2, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)