MedTrace Logo

Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction

NCT07586865 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2026-05-14

No results posted yet for this study

Summary

The goal of this phase IIc clinical trial is to learn if recombinant human thymosin beta 4 injection (NL005) works to treat heart damage in people who have had a serious type of heart attack called ST-segment elevation myocardial infarction (STEMI) and have been treated with emergency percutaneous coronary intervention (PCI, a procedure to open the blocked artery). It will also learn about the safety of NL005. The main questions it aims to answer are:

* Does NL005 lower the size of permanent heart muscle damage measured by cardiac magnetic resonance (CMR) scan 90 days after treatment?
* What medical problems do participants have when taking NL005?

Researchers will compare two different doses of NL005 to a placebo (a look-alike substance that contains no drug) to see if NL005 works better to reduce heart damage caused by the heart attack.

Participants will:

* Receive NL005 or placebo through a vein within 4 hours after the PCI procedure, then once a day for 7 days
* Stay in the hospital for the first week for monitoring, blood draws, and electrocardiograms (heart tracings)
* Have a CMR scan on Day 6 and Day 90 to measure the size of the heart injury
* Return to the hospital for checkups on Day 30 and Day 90
* Be contacted by the study team (by phone or online) 3 times during the first year and come back to the hospital on Day 360 to check long-term recovery

Conditions

  • Acute Myocardial Infarction (AMI)
  • Acute Myocardial Infarction of Anterior Wall
  • Acute Myocardial Infarction With ST Elevation
  • Acute Myocardial Infarction of Left Ventricle
  • Acute Myocardial Infarction With ST Segment Elevation

Interventions

DRUG

Recombinant Human Thymosin Beta 4 Injection (NL005)

NL005 is a sterile solution of recombinant human thymosin beta 4 formulated for intravenous injection. It is supplied as a 1.5 mg (1 mL) vial and stored at 2-8°C. For each dose, the appropriate volume is drawn to achieve 10 µg/kg or 20 µg/kg, and the total volume is adjusted to 5 mL with compatible diluent before administration.

DRUG

Placebo

The placebo is a sterile solution identical in appearance to NL005 and contains no active ingredient. It is supplied as a 1 mL vial and stored at 2-8°C. Each dose is formulated in a total volume of 5 mL and administered intravenously.

Sponsors & Collaborators

  • Beijing Northland Biotech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kefei Dou · Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2027-08-17
Completion
2028-05-17

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 NCT07586865 on ClinicalTrials.gov