A Study of AMDX-2011P in Participants With CAA

NCT05709314 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AMDX-2011P-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebral Amyloid Angiopathy

Keywords

CAA

Outcome Measures

Primary Outcomes (1)

• AMDX-2011P Adverse Events Profile

  Incidence, nature and severity of AEs/SAEs

  8 days

Secondary Outcomes (3)

• Concentration of AMDX-2011P

  2 hours

• Pharmacokinetic Analysis of AMDX-2011P

  2 hours

• Biological Activity

  8 days

Study Arms (1)

AMDX-2011P 100 mg

EXPERIMENTAL

AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Drug: AMDX-2011P

Interventions

AMDX-2011P DRUG

AMDX-2011P single bolus injection intravenous for diagnostic review

AMDX-2011P 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Abnormality consistent with CAA on historical MRI.
• In general good health

You may not qualify if:

• 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.
• Clinically significant laboratory abnormalities assessed by the investigator.
• 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.
• 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.

Sponsors & Collaborators

• Amydis Inc.: lead

Study Sites (1)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matthew Lehman

CONTACT

8599050402; info@amydis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2, open-label, single arm, masked endpoint multicenter study

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)