NCT04891913

SY007 in Patients With Acute Ischemic Stroke

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	SY-007/ Placebo 15mg	15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
DRUG	SY-007/ Placebo 30mg	30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
DRUG	SY-007/ Placebo 60mg	60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-12-25
• Completion: 2023-12-25
• First posted: 2021-05-19
• Last updated: 2022-06-27

Locations

1 site across 1 country: China