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

NCT05485818 | Completed Phase 2

• 1 other identifier: NL005-AMI-IIa
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter randomized double-blind placebo parallel control design was used in this study.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.

Conditions

Acute Myocardial Infarction

Keywords

AMI

Outcome Measures

Primary Outcomes (1)

• Change of myocardial infarction area on Day 5 and day 90 after PCI

  Change of myocardial infarction area on Day 5 and day 90 after PCI. Myocardial infarction area day 5 and day 90 after PCI，and the change on day 90 compared to day 5. Myocardial infarction size was evaluated by late gadolinium enhanced cardiac magnetic resonance (LGE-CMR) imaging.

  Day 5、Day 90

Secondary Outcomes (9)

• Change of myocardial salvage index on Day 5 and day 90 after PCI

  Day 5、Day 90

• Change of microvascular obstruction area on Day 5 and day 90 after PCI

  Day 5、Day 90

• Change of LA on Day 5 and day 90 after PCI

  Day 5、Day 90

• Changeof LV on Day 5 and day 90 after PCI

  Day 5、Day 90

• Change of LVEF on Day 5 and day 90 after PCI

  Day 5、Day 90

Study Arms (4)

Low Dose

EXPERIMENTAL

Patients in this treatment group will receive NL005 for 0.25 ug/kg respective.Continuous administration for 7 days.

Drug: Low Dose

Middle Dose

EXPERIMENTAL

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

Drug: Middle Dose

High Dose

EXPERIMENTAL

Patients in this treatment group will receive NL005 for 2.0 ug/kg respective.Continuous administration for 7 days.

Drug: High Dose

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Low Dose DRUG

12±4 hours after PCI: 0.25 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：0.25 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Also known as: NL005（ Low Dose）

Low Dose

Middle Dose DRUG

12±4 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）

Also known as: NL005（ Middle Dose）

Middle Dose

High Dose DRUG

12±4 hours after PCI: 2.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection），Day2-Day7 after PCI：2.0 ug/kg Recombinant Human Thymosin β4 （intravenous injection）

Also known as: NL005（High Dose）

High Dose

Placebo OTHER

15 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 subject or its legal representative will voluntarily participate in the study and sign the informed consent;
• Age 18 and 75, regardless of gender;
• STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0\~1, see Appendix 1 for TIMI grading) and receiving PCI;
• No obvious collateral of coronary artery (Rentrop grade 0\~1,Rentrop grade see Appendix 2);
• Chest pain occurred for 6 hours and 12 hours before PCI;
• TIMI grade 3 after PCI;
• All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier contraceptive methods, abstinence) during the study period and up to 6 months after the last administration, and women of childbearing age must test negative for pregnancy before administration.

You may not qualify if:

• Patients who have a history of myocardial infarction or have received coronary artery acute thrombolytic interventional therapy with bypass surgery;
• patients who received thrombolytic therapy after onset;
• patients who were clearly diagnosed as acute heart failure (Killip grade II,Killip classification in annex 3);
• Severe arrhythmia that cannot be corrected;
• Aortic dissection or suspected presence;
• Severe liver and kidney dysfunction or severe depletion, etc;
• major surgical history or hemorrhagic stroke in half a year;
• Has or has a history of malignancy;
• Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg in patients with hypertension after active antihypertensive treatment;
• Clinically, he had a significant history of allergy, especially to mannitol, drugs, protein preparations and biological products;
• Screening of patients who participated in other clinical studies within the first 3 months;
• Failure to perform CMR test: such as claustrophobia, renal failure (eGFR \< 30ml/min);

Sponsors & Collaborators

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

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (6)

• Limana F, Capogrossi MC, Germani A. The epicardium in cardiac repair: from the stem cell view. Pharmacol Ther. 2011 Jan;129(1):82-96. doi: 10.1016/j.pharmthera.2010.09.002. Epub 2010 Oct 19.

  PMID: 20937304 BACKGROUND

• Wrigley BJ, Lip GY, Shantsila E. The role of monocytes and inflammation in the pathophysiology of heart failure. Eur J Heart Fail. 2011 Nov;13(11):1161-71. doi: 10.1093/eurjhf/hfr122. Epub 2011 Sep 27.

  PMID: 21952932 BACKGROUND

• Gutierrez SH, Kuri MR, del Castillo ER. Cardiac role of the transcription factor NF-kappaB. Cardiovasc Hematol Disord Drug Targets. 2008 Jun;8(2):153-60. doi: 10.2174/187152908784533702.

  PMID: 18537603 BACKGROUND

• Gordon JW, Shaw JA, Kirshenbaum LA. Multiple facets of NF-kappaB in the heart: to be or not to NF-kappaB. Circ Res. 2011 Apr 29;108(9):1122-32. doi: 10.1161/CIRCRESAHA.110.226928.

  PMID: 21527742 BACKGROUND

• Srivastava D, Ieda M, Fu J, Qian L. Cardiac repair with thymosin beta4 and cardiac reprogramming factors. Ann N Y Acad Sci. 2012 Oct;1270:66-72. doi: 10.1111/j.1749-6632.2012.06696.x.

  PMID: 23050819 BACKGROUND

• Dube KN, Bollini S, Smart N, Riley PR. Thymosin beta4 protein therapy for cardiac repair. Curr Pharm Des. 2012;18(6):799-806. doi: 10.2174/138161212799277699.

  PMID: 22236126 RESULT

Related Links

• Related info

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

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: September 7, 2020
• First Posted: August 3, 2022
• Study Start: November 23, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 18, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)