NCT05542576

Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy

Prospective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Amydis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to assess safety and tolerability of a single intravenous (given through a vein) dose of the investigational retinal tracer AMDX-2011P in patients with neurodegenerative diseases (Parkinson's disease and ALS).

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of three different doses of AMDX-2011P (25mg, 50mg, or 100mg) given as a single intravenous dose in patients with neurodegenerative diseases (Parkinson's disease and ALS). The first cohort of participants taking part in the study will receive the lowest dose of AMDX-2011P (25mg). If no major side effects occur, the dose will be increased for the next group of participants to 50mg and then to 100mg. Secondary objective of this study is to characterize the pharmacokinetic (PK) profile of AMDX-2011P and AMDX-2011. Exploratory evaluations of the biological activity of AMDX-2011P in the retina will be performed by imaging.

Conditions

• Parkinson Disease
• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	AMDX2011P	AMDX2011P single bolus injection intravenous for diagnostic review

Timeline

• Start date: 2022-08-24
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2022-09-15
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study