Chronic Ischemic StrokePhase 1/2NCT07318714
A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke
A Phase 1/2 study testing ASP2246, Brain surgery and Rehabilitation therapy in people with Chronic Ischemic Stroke, run by Astellas Pharma Inc at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Ischemic Stroke
- What is being tested?
- ASP2246, Brain surgery and Rehabilitation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 5 sitesJapan
- Study dates
- 3 Apr 2026to 28 Feb 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant should have had an ischemic cerebral infarction at least 3 months, but not more than 12 months, before signing informed consent. This stroke must be the first-ever stroke for the participant.
- Participant has current neuromotor dysfunction with a modified Rankin Scale (mRS) score between 2 to 4 at screening.
- Participant has Fugl-Meyer Assessment (FMA)- upper extremity (UE) score ≥ 20 to ≤ 50 and FMA-lower extremity (LE) score < 21 at screening.
- Participant has supratentorial perforator area infarction (single lacunar infarction or branch-atheromatous disease [BAD]), as assessed clinically and by magnetic resonance imaging (MRI) at screening.
- Participant has completed recovery phase rehabilitation after cerebral infarction and spontaneous improvement is not expected during the study period.
- Participant is willing and physically able to participate in the designated rehabilitation therapy during the study period.
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- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woma(e)n of childbearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening (Unique to Japan: with a medical interview) and agrees to follow contraceptive guidance from the time of giving informed consent to at least 180 days after surgery.
- Female participant must not be breastfeeding or lactating starting at screening and for 180 days after surgery.
- Female participant must not donate ova after undergoing surgery and for 180 days after surgery.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) for a minimum of 180 days after surgery.
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for a minimum of 180 days after surgery.
- Male participant must not donate sperm for a minimum of 180 days after surgery.
- Participant agrees not to participate in another interventional study (including rehabilitation) while receiving study intervention/participating for up to 52 weeks in the present study.
- Participant agrees that the use of antiplatelet, oral anticoagulant or nonsteroidal anti-inflammatory drugs (NSAIDs) will be determined by the local medical staff in accordance with the American College of Chest Physicians Clinical Pharmacy 2022 Guidelines and the Japanese Guidelines for the Management of Stroke 2021. The Japanese guidelines specify that no antiplatelet, oral anticoagulant or NSAIDs are to be restarted post-surgery until results of the day 1 head MRI or computerized tomography (CT) are reviewed and restarting medication is deemed safe.
Who cannot join
- Participant has a cerebral infarct volume > 3.4 cm^3 or < 0.37 cm^3, as measured by MRI (use of either a central or local reading is acceptable).
- Participant has a primary intracerebral or intracranial hemorrhage.
- Participant has a history of central nervous system (CNS) malignancy or a known presence of any malignancy, unless in remission for > 5 years. Exception: The participant with basal or squamous cell skin cancer that has been successfully treated will be considered eligible even if they have been in remission for < 5 years.
- Participant had motor dysfunction of mRS > 2 before the onset of the stroke (premorbid mRS).
- Participant has a history of seizures.
- Participant has apparent contractures impeding joint movement at shoulder, elbow, forearm, wrist, hand, hip, knee or ankle.
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- Participant with spasticity of grade 2 or higher on the modified Ashworth Scale.
- Participant has any other neurologic, neuromuscular or orthopedic disease that limits motor function.
- Participant has an active infection.
- Participant has a history of or current diagnosis of immunodeficiency.
- Participant has been deemed to have a high risk of recurrent stroke during the study period (e.g., a family history strongly suggestive of hereditary cerebrovascular disease, such as moyamoya disease and cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy).
- Participant has an uncontrolled systemic illness, including, but not limited to, hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg), resistant hypertension (systolic blood pressure [BP] ≥ 140 mmHg or diastolic BP ≥ 90 mmHg in a participant who is taking 3 or more medications for hypertension), bleeding disorders, hypercoagulability, diabetes, renal, hepatic or cardiac failure, morbid obesity, or uncontrolled sleep apnea.
- Participant has any positive findings on tests for occult malignancy, unless a nonmalignant etiology is confirmed.
- Participant has an uncontrolled major psychiatric illness, including depression (Hamilton Score of > 14).
- Participant has a presence of craniectomy (without bone flap replacement) or other contraindication for stereotactic surgery.
- Participant has signs and symptoms of intracranial herniation or increased intracranial pressure.
- Participant with a history of, or electrocardiogram (ECG) evidence suggestive of, recent myocardial infarction (within 6 months of surgery), major dysrhythmia, atrial fibrillation or congestive heart failure.
- Participant has a substance-related and addictive disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 criteria, including drug or alcohol use.
- Participant has contraindications to MRI or MRI contrast agent(s).
- Participant has Montreal Cognitive Assessment (MoCA) score < 26.
- Participant has a history of suicide attempt(s), suicidal behavior, or suicidal ideation (indicated by a 'yes' response to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale [C-SSRS]) within 12 months prior to study enrollment, or who is assessed at screening to be at a significant risk of committing suicide.
- Participant has a history of using warfarin or direct oral anticoagulant (DOAC). Exception: The participant will be considered eligible if the medication was discontinued at least 6 months prior to study enrollment, and the embolic source has resolved without recurrence.
- Participant has a history of neuroleptic drug use. Exception: The participant will be considered eligible if they are neuroleptic medication-free for at least 6 months and their psychiatric symptoms remain mild, stable and do not meet the exclusion criteria.
- Participant has a history of antiepileptic drug use for seizures. Note: For the participant who has used or is using antiepileptic medications for conditions other than seizures, a detailed risk assessment needs to be conducted to determine eligibility.
- Participant has had botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) within the previous 3 months.
- Participant has present or previous history of participation in a study with ASP2246.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has inadequate organ function as indicated by the laboratory values at screening.
- Participant has any condition that makes the participant unsuitable for study participation.
- Participant has known or suspected hypersensitivity to ASP2246 or any components of the formulation used.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo
- Recruiting
Kyoto University Hospital
Kyoto
- Recruiting
Tohoku University Hospital
Sendai, Miyagi
- Recruiting
Tokushima University Hospital
Tokushima
- Recruiting
Toyama University Hospital
Toyama, Toyama
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Chronic Ischemic Stroke
- Being tested
- ASP2246, Brain surgery, Sham surgery, Rehabilitation therapy
- Keywords
- Safety, Tolerability, Efficacy, ASP2246
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2246Drug
Intracerebral parenchymal infusion via SmartFlow Neuro cannula.
Brain surgeryProcedure or surgery
Stereotactic brain surgery
Sham surgeryProcedure or surgery
Sham surgery without the dura incised.
Rehabilitation therapyOther
Rehabilitation 3 days per week for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ASP2246 Dose Escalation (Part 1) | Experimental | Participants will undergo stereotactic brain surgery and receive sequential dose levels of a single intracerebral parenchymal infusion of ASP2246. Participants will undergo rehabilitation therapy. Receives: Drug: ASP2246; Procedure: Brain surgery; Other: Rehabilitation therapy |
| ASP2246 Dose Expansion (Part 2) | Experimental | 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. Receives: Drug: ASP2246; Procedure: Brain surgery; Other: Rehabilitation therapy |
| Sham Dose Expansion (Part 2) | Sham comparator | Participants will undergo a sham surgery and rehabilitation therapy. Receives: Procedure: Sham surgery; Other: Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 52 Weeks
Secondary outcomes (15)
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.
Measured: 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.
Measured: Up to 52 Weeks
PK of ASP2246 in whole blood: maximum concentration (Cmax)
Cmax will be recorded from the PK whole blood samples collected.
Measured: Up to 52 Weeks
PK of ASP2246 in plasma: AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Measured: Up to 52 Weeks
PK of ASP2246 in plasma: AUClast
AUClast will be recorded from the PK plasma samples collected.
Measured: Up to 52 Weeks
PK of ASP2246 in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start3 Apr 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318714
- Sponsor's protocol ID
- 2246-CL-0101
- Other IDs
- jRCT2033250653
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07318714
- Acronym / sponsor ID
- 2246-CL-0101
- Conditions
- Chronic Ischemic Stroke
- Keywords
- Safety, Tolerability, Efficacy, ASP2246
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP2246 Dose Escalation (Part 1) | Experimental | Drug: ASP2246, Procedure: Brain surgery, Other: Rehabilitation therapyParticipants will undergo stereotactic brain surgery and receive sequential dose levels of a single intracerebral parenchymal infusion of ASP2246. Participants will undergo rehabilitation therapy. |
| ASP2246 Dose Expansion (Part 2) | Experimental | Drug: ASP2246, Procedure: Brain surgery, Other: Rehabilitation therapyParticipants 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. |
| Sham Dose Expansion (Part 2) | Sham comparator | Procedure: Sham surgery, Other: Rehabilitation therapyParticipants will undergo a sham surgery and rehabilitation therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participant should have had an ischemic cerebral infarction at least 3 months, but not more than 12 months, before signing informed consent. This stroke must be the first-ever stroke for the participant.
- Participant has current neuromotor dysfunction with a modified Rankin Scale (mRS) score between 2 to 4 at screening.
- Participant has Fugl-Meyer Assessment (FMA)- upper extremity (UE) score ≥ 20 to ≤ 50 and FMA-lower extremity (LE) score < 21 at screening.
- Participant has supratentorial perforator area infarction (single lacunar infarction or branch-atheromatous disease [BAD]), as assessed clinically and by magnetic resonance imaging (MRI) at screening.
- Participant has completed recovery phase rehabilitation after cerebral infarction and spontaneous improvement is not expected during the study period.
Key exclusion criteria (30 listed)
- Participant has a cerebral infarct volume > 3.4 cm^3 or < 0.37 cm^3, as measured by MRI (use of either a central or local reading is acceptable).
- Participant has a primary intracerebral or intracranial hemorrhage.
- Participant has a history of central nervous system (CNS) malignancy or a known presence of any malignancy, unless in remission for > 5 years. Exception: The participant with basal or squamous cell skin cancer that has been successfully treated will be considered eligible even if they have been in remission for < 5 years.
- Participant had motor dysfunction of mRS > 2 before the onset of the stroke (premorbid mRS).
- Participant has a history of seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP2246Intracerebral parenchymal infusion via SmartFlow Neuro cannula. | Drug | ASP2246 Dose Escalation (Part 1), ASP2246 Dose Expansion (Part 2) |
| Brain surgeryStereotactic brain surgery | Procedure or surgery | ASP2246 Dose Escalation (Part 1), ASP2246 Dose Expansion (Part 2) |
| Sham surgerySham surgery without the dura incised. | Procedure or surgery | Sham Dose Expansion (Part 2) |
| Rehabilitation therapyRehabilitation 3 days per week for up to 12 weeks. | Other | ASP2246 Dose Escalation (Part 1), ASP2246 Dose Expansion (Part 2), Sham Dose Expansion (Part 2) |
Primary outcome
Number of participants with Dose-Limiting Toxicity (DLT)
Time frame: Up to 2 Weeks
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).
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 52 Weeks
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.
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 52 Weeks
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.
Number of participants with an Adverse Event of Special Interest (AESI)
Time frame: Up to 52 Weeks
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.
Number of Participants with Suicidal Ideation and/or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 52 Weeks
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.
15 secondary outcomes
Pharmacokinetics (PK) of ASP2246 in whole blood: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
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)
Time frame: Up to 52 Weeks
PK of ASP2246 in whole blood: maximum concentration (Cmax)
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: AUCinf
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: AUClast
Time frame: Up to 52 Weeks
PK of ASP2246 in plasma: Cmax
Time frame: Up to 52 Weeks
Number of participants with anti-polyethylene glycol (PEG) antibodies
Time frame: Up to 52 Weeks
Number of participants with anti-neurogenic differentiation 1 transcription factor (NeuroD1) antibodies
Time frame: Up to 52 Weeks
Change from baseline in proinflammatory cytokine response
Time frame: Baseline and up to Day 8
Change from baseline in complement activation
Time frame: Baseline and up to Day 8
Change from baseline in Fugl-Meyer Assessment (FMA) (motor function) total score
Time frame: Baseline, Week 24 and Week 52
Change from baseline in FMA-UE total score
Time frame: Baseline, Week 24 and Week 52
Change from baseline in FMA-LE total score
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
Time frame: Baseline, Week 24 and Week 52
Change from baseline in mRS score
Time frame: Baseline, Week 24 and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: 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/.
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Hemorrhagic Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Associate Medical Director study director
Astellas Pharma Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASP2246, Brain surgery and Rehabilitation therapy in people with Chronic Ischemic Stroke, run by Astellas Pharma Inc at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astellas Pharma Inc. (+81-3-3244-6500 ext. Japanese only, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose-Limiting Toxicity (DLT) (time frame: Up to 2 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.