Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM621 Cohort 1 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort-Dose 1 |
|
| NGM621 Cohort 2 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort--Dose 2 |
|
| NGM621 Cohort 3 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort--Dose 3 |
|
| NGM621 Cohort 4 Multiple Dose | Experimental | NGM621 multiple IVT injection Cohort--Dose 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM621 | Biological | NGM621 Dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) | The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of NGM621 | Individual and mean serum NGM621 concentration data by cohort. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Arcadia | California | 91007 | United States | ||
| NGM Clinical Study Site |
Not provided
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NGM621 |
| Biological |
NGM621 Dose 2 |
|
| NGM621 | Biological | NGM621 Dose 3 |
|
| NGM621 | Biological | NGM621 Dose 4 |
|
| Newport Beach |
| California |
| 92663 |
| United States |
| NGM Clinical Study Site | Melbourne | Florida | 32901 | United States |
| NGM Clinical Study Site | St. Petersburg | Florida | 33711 | United States |
| NGM Clinical Study Site | Austin | Texas | 78705 | United States |
| NGM Clinical Study Site | The Woodlands | Texas | 77384 | United States |