The purpose of this research study is to assess safety and tolerability of a single intravenous (given through a vein) dose of the investigational retinal tracer AMDX-2011P in patients with neurodegenerative diseases (Parkinson's disease and ALS).
The primary objective of this study is to evaluate the safety and tolerability of three different doses of AMDX-2011P (25mg, 50mg, or 100mg) given as a single intravenous dose in patients with neurodegenerative diseases (Parkinson's disease and ALS). The first cohort of participants taking part in the study will receive the lowest dose of AMDX-2011P (25mg). If no major side effects occur, the dose will be increased for the next group of participants to 50mg and then to 100mg. Secondary objective of this study is to characterize the pharmacokinetic (PK) profile of AMDX-2011P and AMDX-2011. Exploratory evaluations of the biological activity of AMDX-2011P in the retina will be performed by imaging.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
13
AMDX2011P single bolus injection intravenous for diagnostic review
Eye Research Foundation
Newport Beach, California, United States
Brittany NIcholl
Pasadena, California, United States
AMDX-2011P Adverse Events Profile
Incidence of Treatment Emergent Adverse Events (TEAEs) at for each cohort (dose level).
Time frame: 1 week
Concentration of AMDX-2011P
Peak Plasma Concentration (Cmax)
Time frame: 8 hours
Pharmacokinetic Analysis of AMDX-2011P
Area under the plasma concentration versus time curve (AUC)
Time frame: 8 hours
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