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

NCT05984134 | Completed Phase 2

• 1 other identifier: NL005-AMI-IIb
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CMR

Outcome Measures

Primary Outcomes (1)

• Percentage change of myocardial infarction area

  The percentage of myocardial infarction area was defined as the percentage of CMR delayed enhancement area in the entire left ventricular myocardium as measured by plane geometry of computer-assisted enhanced myocardium.Percentage change of myocardial infarction size =D5 percentage of myocardial infarction size -D90 percentage of myocardial infarction size

  Day 5、Day 90

Secondary Outcomes (8)

• Myocardial mass (g)

  Day 5、Day 90

• Myocardial volume (ml)

  Day 5、Day 90

• Myocardial microvessel obstruction area change value

  Day 5、Day 90

• The change of CK-MB before and after administration

  Before the first dose, 12 hours after the first dose, day 2, day 3, day 4

• The area under the CK-MB curve within 4 days

  Before the first dose, 12 hours after the first dose, day 2, day 3, day 4

Study Arms (3)

Middle Dose

EXPERIMENTAL

12 hours after PCI: 0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：0.5 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Drug: NL005 Middle Dose

High Dose

EXPERIMENTAL

12 hours after PCI: 1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：1.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Drug: NL005 High Dose

Placebo

PLACEBO COMPARATOR

Patients in this treatment group will receive placebo respective. Continuous administration for 7 days.

Drug: Placebo

Interventions

NL005 Middle Dose DRUG

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

Also known as: NL005（ Middle Dose）

Middle Dose

NL005 High Dose DRUG

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

Also known as: NL005（ High Dose）

High Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects or their guardians voluntarily participate in the experiment and sign the informed consent;
• Age ≥18 years old and ≤75 years old, gender is not limited;
• STEMI patients with proximal or/and middle occlusion of a single left anterior descending artery (TIMI grade 0-1) and PCI;
• No coronary collateral (Rentrop grade 0);
• meet one of the following conditions:
• The total myocardial ischemia time before PCI was \< 6 hours, and the TIMI grade after PCI was \< 3
• hours ≤ Total myocardial ischemia time before PCI ≤24 hours Note: Total myocardial ischemia time =PCI wire passage time - start time of chest pain
• All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier methods, abstinence) during study participation and up to 6 months of the last dosing, and women of childbearing age must test negative for pregnancy before dosing.

You may not qualify if:

• Patients with a history of myocardial infarction who have received acute coronary thrombolysis, interventional therapy, or bypass surgery; A clear diagnosis of acute heart failure (Killip grade ≥III);
• Severe arrhythmias that cannot be corrected;
• Aortic dissection;
• Severe liver and kidney dysfunction or severe consumption;
• History of major surgery or hemorrhagic stroke within six months;
• Previous history of malignant tumors;
• Hypertensive patients with systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg after active antihypertensive treatment;
• Clinically significant allergic reaction history, especially mannitol, drugs, protein preparations, biological products;
• Patients who participated in other clinical studies within 3 months prior to screening;
• Can not perform CMR examination;

Sponsors & Collaborators

• Beijing Northland Biotech. Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Study Officials

• KeFei Dou

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 9, 2023
• Study Start: July 15, 2022
• Primary Completion: May 26, 2023
• Study Completion: May 29, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)