NCT07318714

A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke

A Phase 1/2 Multicenter, Open-label, Dose Escalation Study Followed by a Randomized, Double-blind Sham-controlled Dose Expansion Study to Evaluate the Safety, Tolerability and Efficacy of ASP2246 in Adult Participants Who Have Motor Dysfunction Associated With Late Subacute to Chronic Ischemic Stroke Due to Supratentorial Perforator Area Infarction

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is for adults who have difficulty moving a few months after a stroke. In this study, ASP2246 will be given to people for the first time. This is known as a "first in human" study. The main aims of the study are to check the safety of ASP2246, how well people tolerate it, and to find suitable doses of ASP2246 to use later in this study and in future studies. This study has 2 parts. In Part 1, people will have brain surgery. During the surgery, different small groups of people will receive a lower to a higher dose of ASP2246. Each dose will be given slowly through a special tube to the damaged part of the brain (intracerebral parenchymal infusion). Any medical problems will be recorded at each dose. This is done to find suitable doses to use in Part 2 of the study. In Part 2, other different groups of people will undergo the same type of brain surgery. Some people will receive a higher dose of ASP2246, and some people will receive a lower dose of ASP2246. These are the doses from Part 1. Also, another group of people won't be given ASP2246 during brain surgery. This is known as a sham procedure. This is done so neither the people taking part in Part 2, nor the study doctors (apart from the surgeons) know who will be given ASP2246. After brain surgery, people will be observed for about 2 weeks. After this, they will have physical therapy and continue to have safety checks for about 1 year after their brain surgery.

Conditions

• Chronic Ischemic Stroke

Interventions

Type	Name	Description
DRUG	ASP2246	Intracerebral parenchymal infusion via SmartFlow Neuro cannula.
PROCEDURE	Brain surgery	Stereotactic brain surgery
PROCEDURE	Sham surgery	Sham surgery without the dura incised.
OTHER	Rehabilitation therapy	Rehabilitation 3 days per week for up to 12 weeks.

Timeline

• Start date: 2026-04-03
• Primary completion: 2030-02-28
• Completion: 2030-02-28
• First posted: 2026-01-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study