Acute Ischemic StrokePhase 1/2ASSENTNCT02586233
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
A Phase 1/2 study testing DS-1040b in people with Acute Ischemic Stroke and Thrombotic Disease, run by Daiichi Sankyo at 55 sites in 11 countries.
Trial summary
This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Thrombotic Disease
- What is being tested?
- DS-1040b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 55 sitesin 11 countries
- Study dates
- Sep 2015to 13 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a clinical diagnosis of acute ischemic stroke (including lacunar stroke/infarct) supported by computed topography or magnetic resonance imaging to rule out alternative cause for presenting symptoms
- Has onset of stroke symptoms within 4.5 to 12 hours before initiation of study drug administration - for subjects with a stroke upon waking, time of symptom onset is the last time the subject was known to be well
- Has a NIHSS score of ≥ 2 (for Cohorts 1-5) and ≥ 5 (for Cohort 6)
- Has Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start completion and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
- Is a Cohort 6 participant who is treated or anticipated to be treated with intra-arterial therapy (IAT) for ischemic stroke at the time of randomization (for enrollment in the IAT subgroup)
- Has given written informed consent to participate in the study prior to participating in any study-related procedures - depending on country-specific practice, written informed consent may be acceptable from legally authorized representative
- Has given a separate written informed consent for collecting a blood sample for genotyping
Who cannot join
- Is a Cohort 1-5 participant who has been treated or is going to be treated with tissue plasminogen activator (tPA) and/or endovascular thrombectomy during current stroke
- Is a Cohort 6 participant treated or anticipated to be treated with tPA during current stroke
- Has evidence of intracranial hemorrhage on non-contrast computed tomography (CT/CAT) scan or magnetic resonance imaging (MRI)
- Has symptoms of subarachnoid hemorrhage, even with normal imaging
- Has an Alberta Stroke Program Early CT Score (ASPECTS) <6
- Has prior non-traumatic intracranial hemorrhage (excluding microhemorrhages observed in imaging)
Show all 26Show fewer
- Has known arteriovenous malformation or aneurysm
- Has evidence of active bleeding
- Has platelet count less than 100,000
- Has International Normalized Ratio greater than 1.7
- Has used unfractionated heparin within 24 hours prior to treatment and has an elevated partial thromboplastin time
- Has used a non-vitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours before treatment
- Has used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment
- Has anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours after completion of study drug treatment (low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment completion and after confirmation of no intracranial bleeding on the 24 hours repeat brain imaging. In Cohort 6, heparin treatment associated with IAT is allowed.)
- Has blood pressure > 185/110 mmHg, or requires aggressive medication to maintain blood pressure below this limit (routine medical treatment including IV drug treatment is allowed to lower the blood pressure below this limit)
- Has had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month
- Has had major surgery within 14 days
- Has had gastrointestinal or genitourinary bleeding in the last 21 days
- Has had a lumbar puncture (or epidural steroid injection) within 14 days
- Has had a preexisting disability classified by modified Rankin Scale (mRS) > 2
- Has an estimated glomerular filtration rate < 60 mL/min/1.73 m^2
- Has baseline hemoglobin < 10.5 g/dL
- Has a positive pregnancy test
- Is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug
- Is an employee or an immediate family member of an employee of the Sponsor, the Contract Research Organization (CRO), or the Site
- Has any other condition the investigator determines would preclude participation in the study
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
United States16 sites
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
Rush University Medical Center
Chicago, Illinois, 60612
UC Health Memorial Hospital
Colorado Springs, Colorado, 80909
Palmetto Health, USC School of Medicine
Columbia, South Carolina, 29203
OSU - Wexner Medical Center
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Health System
Durham, North Carolina, 27710
JFK Neuroscience Institute
Edison, New Jersey, 08820
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Houston Methodist
Houston, Texas, 77030
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
UCLA Medical Center Stroke Network
Los Angeles, California, 90024
University of Louisville
Louisville, Kentucky, 40202
University of South Alabama USA Health System
Mobile, Alabama, 36604
Icahn School Medicine at Mount Sinai
New York, New York, 10029
Oregon Health Sciences University Hospital
Portland, Oregon, 97239
Spain8 sites
Hospital de la santa creu i sant pau C
Barcelona
Vall d'Hebron Hospital
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Universitario Virgen Macarena
Seville
Hospital Virgen del Rocio
Seville
Hospital Clinico Universitario de Valladolid
Valladolid
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza
Italy6 sites
Ospedale di Citta di Castello
Città di Castello, 06018
Ospedale di Branca Largo Unita d'Italia
Gubbio, 06024
Ospedale Guglielmo da Saliceto Via Taverna
Piacenza, 29121
Ospedaliero di Albenga - Pietra Ligure Dept Neurology
Pietra Ligure, 17027
Azienda Ospedaliero Universitaria
Pisa, 56126
Ospedale Borgo Trento
Verona, 37121
Australia4 sites
Royal Adelaide Hospital Neurology Dept.
Adelaide, South Australia, 5000
Monash Health
Clayton, Victoria, 3168
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal North Shore Hospital
Sydney, New South Wales, 2065
Taiwan4 sites
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan, Hsien
United Kingdom4 sites
Queen Elizabeth University Hospital
Glasgow, Scotland
University College Hospitals NHS Foundation Trust
London, England
Salford Royal Hospital
Salford
Royal Stoke University Hospital
Stoke-on-Trent
France3 sites
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25000
Hôpital Pellegrin - CHU Bordeaux
Bordeaux, 33000
CHRU Lille - Hôpital Roger Salengro
Lille, 59037
Germany3 sites
Klinikum Altenburger Land
Altenburg, 04600
Universittsklinikum Essen AR Klinik fr Neurologie
Essen
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main
South Korea3 sites
Pusan National University Hospital
Busan
Seoul National University Bundang Hospital
Seongnam-si
Samsung Medical Center
Seoul
Czechia2 sites
St. Annes University Hospital
Brno
Vitkovicka nemocnice a.s. Zaluzanskeho
Ostrava Vitkovice
Slovakia2 sites
Svet zdravia a.s.,Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota
NsP Spisska Nova Ves
Spišská Nová Ves
About this study
Official title: A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).
- Conditions
- Acute Ischemic Stroke, Thrombotic Disease
- Being tested
- DS-1040b, Placebo
- Keywords
- Acute Ischemic Stroke, Thrombotic disease, DS-1040b
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1040bDrug
Also called Experimental product
DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period
PlaceboDrug
0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period
| Study group | Role | What they receive |
|---|---|---|
| DS-1040b | Experimental | Participants who will be randomized to receive intravenous (IV) infusion of DS-1040b ranging from 0.6 mg to 9.6 mg. Receives: Drug: DS-1040b |
| Placebo | Placebo comparator | Participants who will be randomized to receive intravenous (IV) infusion of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at predose; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-dose state, when the adverse event is continuous.
Measured: Baseline up to 90 days post last dose, up to 3 years 11 months
Secondary outcomes (6)
Summary of Pharmacokinetic (PK) Parameter Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
The PK parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis
Measured: Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration Sampling Point (AUClast) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
The PK parameter of Area Under the Concentration Versus Time Curve from Zero to Last Quantifiable Concentration Sampling Point of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis
Measured: Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Summary of Pharmacokinetic Parameter Terminal Half-life (t1/2) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
The PK parameter of Terminal Half-life of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis in patients with available sample for the analysis.
Measured: Pre-dose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours post-dose
Summary of Activated Form of Thrombin-activatable Fibrinolysis Inhibitor (TAFIa) Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
The enzymatic activity of thrombin-activatable fibrinolysis inhibitor was assessed using the Stago Coagulation Analyzer.
Measured: Baseline and 6 hours postdose
Summary of Changes From Baseline at Day 30 in National Institute of Health Stroke Scale (NIHSS) Score Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
The National Institute of Health Stroke Scale (NIHSS) quantifies stroke severity based on weighted evaluation findings. The score for each ability is a number between 0 and 4, with 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score indicates more impairment (worse outcome) in a stroke patient.
Measured: 30 days post dose
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 to 2 Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
The modified Rankin scale (mRS) is a commonly used disability scale derived from the Rankin scale that is used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The level of disability following a stroke is assessed via a scale from 0 to 6, where 0 is no symptoms at all and 6 indicates death. Higher scores indicate worse outcome. The percentage of participants with an mRS score of 0 to 2 at Day 5 (baseline) and Day 90 is being reported.
Measured: Day 5 (baseline) and Day 90 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586233
- Sponsor's protocol ID
- DS1040-A-U103
- Other IDs
- 2015-001824-43, 2015
- Acronym
- ASSENT
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2015
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02586233
- Acronym / sponsor ID
- ASSENT / DS1040-A-U103
- Conditions
- Acute Ischemic Stroke, Thrombotic Disease
- Keywords
- Acute Ischemic Stroke, Thrombotic disease, DS-1040b
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS-1040b | Experimental | Drug: DS-1040bParticipants who will be randomized to receive intravenous (IV) infusion of DS-1040b ranging from 0.6 mg to 9.6 mg. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants who will be randomized to receive intravenous (IV) infusion of placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a clinical diagnosis of acute ischemic stroke (including lacunar stroke/infarct) supported by computed topography or magnetic resonance imaging to rule out alternative cause for presenting symptoms
- Has onset of stroke symptoms within 4.5 to 12 hours before initiation of study drug administration - for subjects with a stroke upon waking, time of symptom onset is the last time the subject was known to be well
- Has a NIHSS score of ≥ 2 (for Cohorts 1-5) and ≥ 5 (for Cohort 6)
- Has Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start completion and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
- Is a Cohort 6 participant who is treated or anticipated to be treated with intra-arterial therapy (IAT) for ischemic stroke at the time of randomization (for enrollment in the IAT subgroup)
Key exclusion criteria (26 listed)
- Is a Cohort 1-5 participant who has been treated or is going to be treated with tissue plasminogen activator (tPA) and/or endovascular thrombectomy during current stroke
- Is a Cohort 6 participant treated or anticipated to be treated with tPA during current stroke
- Has evidence of intracranial hemorrhage on non-contrast computed tomography (CT/CAT) scan or magnetic resonance imaging (MRI)
- Has symptoms of subarachnoid hemorrhage, even with normal imaging
- Has an Alberta Stroke Program Early CT Score (ASPECTS) <6
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 |
|---|---|---|
| DS-1040bAlso: Experimental productDS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period | Drug | DS-1040b |
| Placebo0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period | Drug | Placebo |
Primary outcome
Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Time frame: Baseline up to 90 days post last dose, up to 3 years 11 months
Treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at predose; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-dose state, when the adverse event is continuous.
6 secondary outcomes
Summary of Pharmacokinetic (PK) Parameter Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Time frame: Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration Sampling Point (AUClast) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Time frame: Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Summary of Pharmacokinetic Parameter Terminal Half-life (t1/2) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Time frame: Pre-dose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours post-dose
Summary of Activated Form of Thrombin-activatable Fibrinolysis Inhibitor (TAFIa) Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Time frame: Baseline and 6 hours postdose
Summary of Changes From Baseline at Day 30 in National Institute of Health Stroke Scale (NIHSS) Score Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Time frame: 30 days post dose
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 to 2 Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Time frame: Day 5 (baseline) and Day 90 post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DS-1040b in people with Acute Ischemic Stroke and Thrombotic Disease, run by Daiichi Sankyo at 55 sites in 11 countries.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Spain, Italy, Australia, Taiwan and 6 more countries. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke (time frame: Baseline up to 90 days post last dose, up to 3 years 11 months). 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 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.