Acute Ischemic Stroke
Conditions
Brief 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. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
Interventions
DRUGSY-007/ Placebo 15mg
15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
DRUGSY-007/ Placebo 30mg
30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
DRUGSY-007/ Placebo 60mg
60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Sponsors
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 Key
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerance of SY-007 | From Day 0 to Day 90 | Number of patients with treatment-emergent adverse events and number of patients who died over 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Excellent Outcome in Modified Rankin Scale（mRS) Score at Day 8, Day30, Day60, Day90 | Day 8, Day30, Day60, Day90 | Excellent mRS is defined as mRS score of 0 or 1 |
| Modified Rankin Scale Score at Day 8, Day30, Day60, Day90 | Day 8, Day30, Day60, Day90 | Modified Rankin Scale Score range from 0 to 5，higher score mean a worse outcome. |
| Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30 | Day 8, Day30 | — |
| Pharmacokinetics of SY-007 | From Day 0 to Day 7 | Peak Plasma Concentration (Cmax) |
| Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90 | 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. |
| Change of Cerebral infarction volume before and after treatment | Baseline, Day 8, Day30 | — |
| Immunogenicity of SY-007 | From Day 0 to Day 30 | Anti-Drug antibody evaluation |
| Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30 | Day 8, Day30 | — |
Countries
China
Outcome results
None listed