Health TrialsbyHealthPanel

A Study of AMDX-2011P in Participants With CAA

ConditionCerebral Amyloid Angiopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmydis Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • AMDX-2011P

    Drug

    AMDX-2011P single bolus injection intravenous for diagnostic review

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: AMDX-2011P 100 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AMDX-2011P Adverse Events Profile

Incidence, nature and severity of AEs/SAEs

Time frame
8 days

Secondary outcomes

1

Concentration of AMDX-2011P

Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011

Time frame
2 hours
2

Pharmacokinetic Analysis of AMDX-2011P

Area under the plasma versus time curve (AUC)

Time frame
2 hours
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amydis Inc.

Lead sponsor

Source ClinicalTrials.gov
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