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Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury

NCT03995732 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-26

No results posted yet for this study

Summary

The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.

Conditions

  • Myocardial Reperfusion Injury

Interventions

DRUG

PC-SOD

PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.

DRUG

placebo

Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Beijing Tide Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2020-10-31
Completion
2021-03-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03995732 on ClinicalTrials.gov