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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX007-GLA-01 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX007 | Biological | Single ascending dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by the occurrence of adverse events | Day 56 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a single IVT injection of ANX007 on serum C1q | Day 15 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Humphriss | Annexon Vice President of Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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