NCT07215403

Prescriptive Infusion Algorithm (PIA)

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: AskBio Inc · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Participants will receive a one-time infusion of AB-1005 directly into the putamen on each side of the brain. This is done during a surgical procedure under general anesthesia. The drug is delivered using a special technique called convection-enhanced delivery (CED), which helps spread the drug evenly in the target brain tissue. The delivery method will use either MRI or CT scans to guide and check the placement of the infusion needle (cannula, which is a thin tube). The study has two main stages, each with two small groups (sub-stages) of 3 participants. Each group will receive the same treatment, and results will be reviewed before moving to the next group. All participants will receive AB-1005. The study is open-label, meaning both participants and doctors know what treatment is given. After the follow-up period, all participants will continue into a long-term follow-up (LTFU) study. In the LTFU study, participants' health will be monitored for up to 10 years after their surgery.

Conditions

• PARKINSON DISEASE (Disorder)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-30
• Completion: 2028-03-01
• First posted: 2025-10-10
• Last updated: 2025-10-10

Regulatory

• FDA-regulated drug study