SY007 in Patients With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Phase Ib Clinical Study to Evaluate Safety, Tolerance，Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04891913
• Other study ID #: SY007002
• Status: Suspended
• Phase: Phase 1
• Start date: July 1, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: June 2022
• Source: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 36
• Est. completion date: December 25, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• SY-007/ Placebo 15mg
15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
• SY-007/ Placebo 30mg
30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
• SY-007/ Placebo 60mg
60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerance of SY-007	Number of patients with treatment-emergent adverse events and number of patients who died over 90 days	From Day 0 to Day 90
Secondary	Pharmacokinetics of SY-007	Peak Plasma Concentration (Cmax)	From Day 0 to Day 7
Secondary	Pharmacokinetics of SY-007	Area under the plasma concentration versus time curve (AUC)	From Day 0 to Day 7
Secondary	Pharmacokinetics of SY-007	Time to Cmax (Tmax)	From Day 0 to Day 7
Secondary	Pharmacokinetics of SY-007	Terminal half life (T½)	From Day 0 to Day 7
Secondary	Pharmacokinetics of SY-007	Clearance (CL)	From Day 0 to Day 7
Secondary	Pharmacokinetics of SY-007	Volume of distribution	From Day 0 to Day 7
Secondary	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	Day 8, Day30, Day60, Day90
Secondary	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.	Day 8, Day30, Day60, Day90
Secondary	Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30		Day 8, Day30
Secondary	Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30		Day 8, Day30
Secondary	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.	Day 8, Day30, Day60, Day 90
Secondary	Change of Cerebral infarction volume before and after treatment		Baseline, Day 8, Day30
Secondary	Immunogenicity of SY-007	Anti-Drug antibody evaluation	From Day 0 to Day 30