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Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction

NCT05984134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-06-21

No results posted yet for this study

Summary

A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90 days after PCI.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

NL005 Middle Dose

Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.

DRUG

NL005 High Dose

Patients in this treatment group will receive NL005 for 1.5 ug/kg respective.Continuous administration for 7 days.

DRUG

Placebo

30 subjects will be randomly assigned to the placebo for 7 days

Sponsors & Collaborators

  • Beijing Northland Biotech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • KeFei Dou · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-05-26
Completion
2023-05-29

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 NCT05984134 on ClinicalTrials.gov