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NOT YET RECRUITING
NCT07215403
PHASE2

Prescriptive Infusion Algorithm (PIA)

Sponsor: AskBio Inc

View on ClinicalTrials.gov

Summary

This study is being done to test a new way of delivering AB-1005 into the brain. The goal is to make the procedure easier and quicker to perform, while providing similar amounts of drug to the part of the brain that needs treatment. Technical (Stage 1) To test if the new delivery method (PIA-based infusion) can consistently deliver AB-1005 to the putamen using brain imaging by MRI. Technical (Stage 2) To confirm the new delivery method works without brain imaging by MRI, using standard operating room tools including brain imaging by CT. Safety (Stage 1 and 2) To assess the safety and tolerability of the new delivery method for AB-1005 up to 6 months after surgery

Official title: Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-05-01

Completion Date

2028-03-01

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

PROCEDURE

Prescriptive Infusion Algorithm

The study intervention is comprised of the neurosurgical procedure and the bilateral intraputaminal delivery of AB-1005.

DRUG

AB-1005

bilateral intraputaminal delivery of AB-1005