A Phase 1/2 interventional study of ASP2246 and Brain surgery in Chronic Ischemic Stroke, sponsored by Astellas Pharma Inc. Recruiting at 5 sites in Japan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Astellas Pharma Inc · Phase 1/2, Interventional, and Treatment
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. For people in Part 1, this will take place in the hospital. For people in Part 2, the observation in hospital may be longer or shorter, depending on the results from Part 1. People in both Parts 1 and 2 will have physical therapy for 12 weeks after surgery and continue to have safety checks for about 1 year after their brain surgery.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 84 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participant is not pregnant and at least 1 of the following conditions apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo stereotactic brain surgery and receive sequential dose levels of a single intracerebral parenchymal infusion of ASP2246. Participants will undergo rehabilitation therapy.
Drug: ASP2246 · Procedure: Brain surgery · Other: Rehabilitation therapy
Participants will undergo stereotactic brain surgery and receive a single intracerebral parenchymal infusion of ASP2246. The dosage will be selected from Dose Escalation (Part 1). Participants will undergo rehabilitation therapy.
Drug: ASP2246 · Procedure: Brain surgery · Other: Rehabilitation therapy
Participants will undergo a sham surgery and rehabilitation therapy.
Procedure: Sham surgery · Other: Rehabilitation therapy
Intracerebral parenchymal infusion via SmartFlow Neuro cannula.
Stereotactic brain surgery
Sham surgery without the dura incised.
Rehabilitation 3 days per week for up to 12 weeks.
Number of participants with Dose-Limiting Toxicity (DLT)
A DLT will be defined as an Adverse Event (AE) ≥ 3 Grade that occurs during the 2-week DLT evaluation period and is attributed to study intervention or surgical procedure. This determination will be based on the investigator's initial assessment of causality and will be confirmed by the Dose Escalation and Safety Committee (DESC). A Grade 3 AE is defined as a severe or medically significant event that is not immediately life-threatening, but may cause hospitalization or prolongation of hospitalization, be disabling, or limit a patient's ability to perform self-care activities of daily living (ADL).
Time frame: Up to 2 Weeks
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. A TEAE is defined as an AE observed until 52 weeks after surgery on day 1.
Time frame: Up to 52 Weeks
Number of participants with Serious Adverse Events (SAEs)
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations.
Time frame: Up to 52 Weeks
Number of participants with an Adverse Event of Special Interest (AESI)
An AESI includes intracranial hemorrhage, cerebral edema (local or extensive), meningitis/encephalitis/encephalopathy (infectious or aseptic), seizures, worsening or new onset of neurologic deficits, intracranial malignancies/tumor formation, and immunogenic reactions.
Time frame: Up to 52 Weeks
Number of Participants with Suicidal Ideation and/or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a validated, clinician-administered tool used to assess suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.
Time frame: Up to 52 Weeks
Pharmacokinetics (PK) of ASP2246 in whole blood: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK whole blood samples collected.
Time frame: Up to 52 Weeks
PK of ASP2246 in whole blood: AUC from the time of dosing up to the time of the last measurable concentration (AUClast)
AUClast will be recorded from the PK whole blood samples collected.
Time frame: Up to 52 Weeks
PK of ASP2246 in whole blood: maximum concentration (Cmax)
Cmax will be recorded from the PK whole blood samples collected.
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to 52 Weeks
Number of participants with anti-polyethylene glycol (PEG) antibodies
Anti-PEG antibody status will be recorded from the serum samples collected.
Time frame: Up to 52 Weeks
Number of participants with anti-neurogenic differentiation 1 transcription factor (NeuroD1) antibodies
Anti-NeuroD1 antibody status will be recorded from the serum samples collected.
Time frame: Up to 52 Weeks
Change from baseline in proinflammatory cytokine response
Cytokines will be measured using immunoassay with fluorescence detection. Concentration will be recorded from serum samples collected.
Time frame: Baseline and up to Day 8
Change from baseline in complement activation
Complement activation components will be measured using immunoassay with fluorescence detection. Concentration will be recorded from the plasma samples collected.
Time frame: Baseline and up to Day 8
Change from baseline in Fugl-Meyer Assessment (FMA) (motor function) total score
The FMA consists of five domains: motor function, sensory function, balance, joint range of motion, and joint pain, evaluating a total of 155 items. In this study, only the motor function score will be utilized to capture motor-specific changes. The motor function score ranges from 0 (hemiplegia) to 100 points (normal motor function), combing scores from upper extremity (UE) assessment and lower extremity (LE) assessment.
Time frame: Baseline, Week 24 and Week 52
Change from baseline in FMA-UE total score
FMA-UE evaluates movements of the shoulder, elbow, forearm, wrist, hand as well as coordination and reflex actions.
Time frame: Baseline, Week 24 and Week 52
Change from baseline in FMA-LE total score
FMA-LE evaluates movements of the hip, knee, ankle as well as coordination and reflex actions.
Time frame: Baseline, Week 24 and Week 52
Number of participants with decrease of at least 1 point from baseline in modified Rankin Scale (mRS) score
The mRS ranges from 0 (no symptoms) to 6 (deceased), capturing levels of disability from full independence to severe dependence.
Time frame: Baseline, Week 24 and Week 52
Change from baseline in mRS score
The mRS ranges from 0 (no symptoms) to 6 (deceased), capturing levels of disability from full independence to severe dependence.
Time frame: Baseline, Week 24 and Week 52
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
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