NCT04891913

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

May 10, 2021

Last Update Submit

June 20, 2022

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Pharmacokinetics of SY-007

    From Day 0 to Day 7

  • Pharmacokinetics of SY-007

    From Day 0 to Day 7

  • Pharmacokinetics of SY-007

    From Day 0 to Day 7

  • Pharmacokinetics of SY-007

    From Day 0 to Day 7

  • Pharmacokinetics of SY-007

    From Day 0 to Day 7

  • +8 more secondary outcomes

Study Arms (3)

15mg SY-007/ Placebo Repeat Dose

EXPERIMENTAL

Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days.

Drug: SY-007/ Placebo 15mg

30mg SY-007/ Placebo Repeat Dose

EXPERIMENTAL

Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days.

Drug: SY-007/ Placebo 30mg

60mg SY-007/ Placebo Repeat Dose

EXPERIMENTAL

Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days.

Drug: SY-007/ Placebo 60mg

Interventions

SY-007/ Placebo 15mgDRUG

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

15mg SY-007/ Placebo Repeat Dose
SY-007/ Placebo 30mgDRUG

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

30mg SY-007/ Placebo Repeat Dose
SY-007/ Placebo 60mgDRUG

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

60mg SY-007/ Placebo Repeat Dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

July 1, 2023

Primary Completion

December 25, 2023

Study Completion

December 25, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations

CN(1)