drugset / Trial / NCT07215403

Prescriptive Infusion Algorithm (PIA)

NCT07215403 ↗

Phase 2 Not yet recruiting 18 enrolled AskBio Inc Bayer · collab
NaSequentialOpen-labelTreatment

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 0) To test if the new delivery method (prefrontal surgical approach) can consistently deliver AB-1005 to the putamen using MRI monitoring. 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

Timeline

Start
2026-07-15
Primary completion
2027-12-30
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject AB-1005 Unknown — Other

Indications