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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Safety and tolerance of SY-007
Number of patients with treatment-emergent adverse events and number of patients who died over 90 days
Time frame: From Day 0 to Day 90
Pharmacokinetics of SY-007
Peak Plasma Concentration (Cmax)
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Area under the plasma concentration versus time curve (AUC)
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Time to Cmax (Tmax)
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Terminal half life (T½)
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Clearance (CL)
Time frame: From Day 0 to Day 7
Pharmacokinetics of SY-007
Volume of distribution
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
Excellent mRS is defined as mRS score of 0 or 1
Time frame: Day 8, Day30, Day60, Day90
Modified Rankin Scale Score at Day 8, Day30, Day60, Day90
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Modified Rankin Scale Score range from 0 to 5,higher score mean a worse outcome.
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
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.
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
Anti-Drug antibody evaluation
Time frame: From Day 0 to Day 30