Recruiting
Phase 2

AMDX-2011P

Sponsor:

Amydis Inc.

Code:

NCT05709314

Conditions

Cerebral Amyloid Angiopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AMDX-2011P

Study Details

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

Study ID

NCT05709314

Start date

Jul 9, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: AMDX-2011P 100 mg

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

Interventions

AMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Primary outcome measure

  • AMDX-2011P Adverse Events Profile [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

Locations

Associated Retina Consultants

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

More Information

Sponsor

Amydis Inc.

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • CAA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amydis Inc. on 2026-02-13.