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NCT Number: NCT04284514

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

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Primary Open Angle Glaucoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD, Austin, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKB-9778 Ophthalmic Solution

Drug

AKB-9778 Ophthalmic Solution

Placebo Ophthalmic Solution

Drug

Matched vehicle-control

Primary outcomes

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

    Time frame: Baseline to Day 7

  2. Vital sign- systolic and diastolic blood pressure

    Time frame: Baseline to Day 7

    Systolic and diastolic blood pressure in mmHg

  3. Complete blood count

    Time frame: Baseline to Day 7

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

Secondary outcomes

  1. Intraocular pressure

    Time frame: Baseline to Day 7

    Intraocular pressure in mmHg

  2. AKB-9778 concentration

    Time frame: Baseline to Day 7

    Measurement of AKB-9778 in plasma after drug administration

Sponsors and collaborators

Lead sponsor

Aerpio Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2020
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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