Actively Recruiting
A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)
Led by Amydis Inc. · Updated on 2026-02-13
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, plasma pharmacokinetics, and biological activity of a single intravenous dose of AMDX-2011P in adults with cerebral amyloid angiopathy (CAA). This open-label, phase 2 study aims to understand how this drug behaves in the body and its effects related to CAA, a condition characterized by the accumulation of amyloid in the brain's blood vessels. The study also involves retinal imaging assessments conducted by masked reviewers to explore the drug's diagnostic potential. Participants will receive a single intravenous bolus injection of 100 mg AMDX-2011P. Before the injection, participants undergo eye examinations and retinal imaging. After administration, safety assessments, additional retinal imaging, and blood samples for pharmacokinetic analysis will be collected. The study primarily monitors adverse events over 8 days, with pharmacokinetic and biological activity evaluations within the first 2 hours following the dose. During the study, participants will be admitted to the study site for all procedures including eye exams, imaging, drug administration, and safety monitoring. Researchers will track the drug's concentration in plasma, assess any side effects, and evaluate biological activity. The total monitoring period for adverse events extends for 8 days after dosing. This study is sponsored by Amydis Inc. and is expected to conclude in December 2026.
CONDITIONS
Brief Title
A Study of AMDX-2011P in Participants With CAA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hereditary or probable/definite symptomatic or asymptomatic sporadic cerebral amyloid angiopathy confirmed by genetic testing or modified Boston neuroradiological criteria
- At least one prior brain magnetic resonance imaging (MRI) showing abnormalities consistent with cerebral amyloid angiopathy
- Generally in good health
You will not qualify if you...
- Any physical or psychological medical condition that may prevent completion of the study
- Clinically significant laboratory abnormalities
- Active cancer or cancer history in the past 5 years, except for completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia
- Prolonged QTcF, cardiac arrhythmia, or significant resting ECG abnormalities as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 days
Participants receive a single intravenous bolus injection of AMDX-2011P followed by safety assessments, retinal imaging, and blood collection for pharmacokinetic analysis.
1 admission visit with dosing and multiple safety and imaging assessments up to 8 days
Trial Site Locations
Total: 1 location
1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Actively Recruiting
Research Team
M
Matthew Lehman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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