Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma

Study Overview
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Brief Summary
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This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

Detailed Description
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This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.

Official Title
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A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Biological: ANX007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18 years and older Diagnosis of primary open-angle glaucoma Intraocular pressure <21 mm Hg on a stable IOP treatment regimen Reliable visual field testing Exclusion Criteria: BCVA worse than 20/80 in either eye Extensive glaucomatous visual-field damage History of intraocular inflammatory or infectious eye disease in study eye Ocular trauma in study eye within the preceding 6 months History of uncomplicated cataract surgery less than 6 mos prior Any abnormality preventing reliable Tonopen tonometry in study eye Active malignancy within past 5 yrs Previous tx with another humanized monoclonal antibody History of any autoimmune or neurologic disease Concurrent use of glucocorticoid medications Receiving monoamine oxidase inhibitor therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANX007-GLA-01<br> | Biological: ANX007<br>* Single ascending dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by the occurrence of adverse events |  | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum plasma concentration of ANX007 after a single IVT injection. |  | Day 15 | 
| Immunogenicity of ANX007 after a single IVT injection. |  | Day 56 |