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The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with cerebral amyloid angiopathy (CAA).
This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with CAA. Assessments of retinal images will be conducted by central masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMDX-2011P 100 mg | Experimental | AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMDX-2011P | Drug | AMDX-2011P single bolus injection intravenous for diagnostic review |
|
| Measure | Description | Time Frame |
|---|---|---|
| AMDX-2011P Adverse Events Profile | Incidence, nature and severity of AEs/SAEs | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of AMDX-2011P | Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011 | 2 hours |
| Pharmacokinetic Analysis of AMDX-2011P | Area under the plasma versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Lehman | Contact | 8599050402 | info@amydis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Recruiting | Phoenix | Arizona | 85020 | United States |
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| ID | Term |
|---|---|
| D016657 | Cerebral Amyloid Angiopathy |
| ID | Term |
|---|---|
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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Phase 2, open-label, single arm, masked endpoint multicenter study
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| 2 hours |
| Biological Activity | Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device. | 8 days |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |