Acute Ischemic StrokePhase 1NCT04891913
SY007 in Patients With Acute Ischemic Stroke
A Phase 1 study of Acute Ischemic Stroke, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
Trial summary
This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 25 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Aged from18 Years to 80 Years
- Within 24h after the onset of stroke symptoms (time the patient was last seen well)
- Score range from 4 to 20 points, inclusive, on the NIHSS at randomization
- Prior to index stroke, patient was able to perform basic activities of daily living without assistance, mRS score≤1
- Absence of intracranial hemorrhage on brain CT or MRI
- Patients or legal representatives can give informed consent
Who cannot join
- Venous thrombolytic therapy or endovascular treatments have been applied for patients; or Patients plan to conduct these kind of treatments.
- Glasgow score of Patients ≤8
- Patients are receiving oral anticoagulants or INR>3.0
- Baseline blood platelet counts <80*109/L
- NIHSS score could not been obtained at baseline
- FPG levels < 50mg/dL or >400mg/dL
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- Patients with Kidney disorder eGFR <30 mL/min or patients need dialysis
- Patients with Acute and Chronic hepatitis, or Liver diseases (AST or/and ALT >2 × ULN(upper limit normal))
- systolic blood pressure≥220mmHg or/and diastolic blood pressure≥120mmHg ; or Blood pressure under 90/60mmHg.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing
About this study
Official title: Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects
This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
- Conditions
- Acute Ischemic Stroke
- Being tested
- SY-007/ Placebo 15mg, SY-007/ Placebo 30mg, SY-007/ Placebo 60mg
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-007/ Placebo 15mgDrug
15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
SY-007/ Placebo 30mgDrug
30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
SY-007/ Placebo 60mgDrug
60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 15mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days. Receives: Drug: SY-007/ Placebo 15mg |
| 30mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days. Receives: Drug: SY-007/ Placebo 30mg |
| 60mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days. Receives: Drug: SY-007/ Placebo 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance of SY-007
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
Measured: From Day 0 to Day 90
Secondary outcomes (13)
Pharmacokinetics of SY-007
Peak Plasma Concentration (Cmax)
Measured: From Day 0 to Day 7
Pharmacokinetics of SY-007
Area under the plasma concentration versus time curve (AUC)
Measured: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time to Cmax (Tmax)
Measured: From Day 0 to Day 7
Pharmacokinetics of SY-007
Terminal half life (T½)
Measured: From Day 0 to Day 7
Pharmacokinetics of SY-007
Clearance (CL)
Measured: From Day 0 to Day 7
Pharmacokinetics of SY-007
Volume of distribution
Measured: From Day 0 to Day 7
Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90
Excellent mRS is defined as mRS score of 0 or 1
Measured: Day 8, Day30, Day60, Day90
Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
Modified Rankin Scale Score range from 0 to 5，higher score mean a worse outcome.
Measured: Day 8, Day30, Day60, Day90
Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30
Measured: Day 8, Day30
Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30
Measured: Day 8, Day30
Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90
Excellent BI outcome is defined as a score of >=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility.
Measured: Day 8, Day30, Day60, Day 90
Change of Cerebral infarction volume before and after treatment
Measured: Baseline, Day 8, Day30
Immunogenicity of SY-007
Anti-Drug antibody evaluation
Measured: From Day 0 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jul 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Why it stopped: The sponsor decided to suspend the process
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891913
- Sponsor's protocol ID
- SY007002
- Status last verified
- Jun 2022
- First submitted
- 10 May 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects
- ClinicalTrials.gov ID
- NCT04891913
- Acronym / sponsor ID
- SY007002
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor decided to suspend the process
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 19 May 2021 (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 Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15mg SY-007/ Placebo Repeat Dose | Experimental | Drug: SY-007/ Placebo 15mgIntravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days. |
| 30mg SY-007/ Placebo Repeat Dose | Experimental | Drug: SY-007/ Placebo 30mgIntravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days. |
| 60mg SY-007/ Placebo Repeat Dose | Experimental | Drug: SY-007/ Placebo 60mgIntravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from18 Years to 80 Years
- Within 24h after the onset of stroke symptoms (time the patient was last seen well)
- Score range from 4 to 20 points, inclusive, on the NIHSS at randomization
- Prior to index stroke, patient was able to perform basic activities of daily living without assistance, mRS score≤1
- Absence of intracranial hemorrhage on brain CT or MRI
Key exclusion criteria (9 listed)
- Venous thrombolytic therapy or endovascular treatments have been applied for patients; or Patients plan to conduct these kind of treatments.
- Glasgow score of Patients ≤8
- Patients are receiving oral anticoagulants or INR>3.0
- Baseline blood platelet counts <80*109/L
- NIHSS score could not been obtained at baseline
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 |
|---|---|---|
| SY-007/ Placebo 15mg15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. | Drug | 15mg SY-007/ Placebo Repeat Dose |
| SY-007/ Placebo 30mg30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. | Drug | 30mg SY-007/ Placebo Repeat Dose |
| SY-007/ Placebo 60mg60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. | Drug | 60mg SY-007/ Placebo Repeat Dose |
Primary outcome
Safety and tolerance of SY-007
Time frame: From Day 0 to Day 90
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
13 secondary outcomes
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time frame: From Day 0 to Day 7
Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90
Time frame: Day 8, Day30, Day60, Day90
Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
Time frame: Day 8, Day30, Day60, Day90
Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30
Time frame: Day 8, Day30
Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30
Time frame: Day 8, Day30
Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90
Time frame: Day 8, Day30, Day60, Day 90
Change of Cerebral infarction volume before and after treatment
Time frame: Baseline, Day 8, Day30
Immunogenicity of SY-007
Time frame: From Day 0 to Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Acute Ischemic Stroke, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
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 6 inclusion and 9 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: paused, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety and tolerance of SY-007 (time frame: From Day 0 to Day 90). 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 27 Jun 2022.