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SY007 in Patients With Acute Ischemic Stroke

NCT04891913 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Suzhou Yabao Pharmaceutical R&D Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-12-25
Completion
2023-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891913 on ClinicalTrials.gov