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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05709314
Other study ID # AMDX-2011P-001
Secondary ID 5SB1AG073029-02
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 2024
Est. completion date December 2024

Study information

Verified date March 2024
Source Amydis Inc.
Contact Joyce Simpauco, MPH
Phone 858-254-7435
Email joyce@amydis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of hereditary CAA or probable and definite symptomatic or asymptomatic sporadic CAA diagnosed through genetic testing or according to the modified Boston neuroradiological criteria, who had undergone at least one brain magnetic resonance imaging (MRI)prior to entry into study. 2. Abnormality consistent with CAA on historical MRI. 3. In general good health Exclusion Criteria: 1. Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol. 2. Clinically significant laboratory abnormalities assessed by the investigator. 3. Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia. 4. Prolonged QTcF (>450 ms for males and >470 ms for females),cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

Locations

Country Name City State
United States Global Research Management Glendale California
United States Eye Research Foundation Newport Beach California
United States Associated Retina Consultants Phoenix Arizona

Sponsors (3)

Lead Sponsor Collaborator
Amydis Inc. National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AMDX-2011P Adverse Events Profile Incidence, nature and severity of AEs/SAEs 8 days
Secondary Concentration of AMDX-2011P Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011 2 hours
Secondary Pharmacokinetic Analysis of AMDX-2011P Area under the plasma versus time curve (AUC) 2 hours
Secondary Biological Activity Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device. 8 days
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