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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
AMDX-2011P single bolus injection intravenous for diagnostic review
Associated Retina Consultants
Phoenix, Arizona, United States
RECRUITINGAMDX-2011P Adverse Events Profile
Incidence, nature and severity of AEs/SAEs
Time frame: 8 days
Concentration of AMDX-2011P
Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011
Time frame: 2 hours
Pharmacokinetic Analysis of AMDX-2011P
Area under the plasma versus time curve (AUC)
Time frame: 2 hours
Biological Activity
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.
Time frame: 8 days
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