A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction

NCT07091929 | Completed Phase 1 FDA Drug

• 1 other identifier: SG-SGC001-102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief Summary

The research study is being done to see if SGC001 can be used to treat people scheduled to undergo percutaneous coronary intervention for Anterior ST-segment Elevation Myocardial Infarction. SGC001 might reduce the infarct size and inhibited inflammation, thereby preventing the incidence of major adverse cardiovascular events(MACE) events. Participants will either get SGC001 (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting SGC001 or placebo is the same. The participant was administered intravenously once. SGC001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe.

Conditions

Anterior Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Adverse events (AE), Serious adverse events (SAE)

  Adverse events (AE), Serious adverse events (SAE)

  From randomisation to end-of-study (up to 30 days)

• Recommended Phase 2 dose (RP2D)

  Determination of the Recommended Phase II Dose

  From randomisation to end-of-study (up to 30 days)

Secondary Outcomes (18)

• Peak Concentration (Cmax)

  From randomisation to end-of-study (up to 30 days)

• Time to Maximum Concentration (Tmax)

  From randomisation to end-of-study (up to 30 days)

• Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)

  From randomisation to end-of-study (up to 30 days)

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

  From randomisation to end-of-study (up to 30 days)

• Elimination half-life (t1/2)

  From randomisation to end-of-study (up to 30 days)

Study Arms (2)

SGC001

EXPERIMENTAL

Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of SGC001 on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.

Drug: SGC001

Placebo

PLACEBO COMPARATOR

Enrolled anterior STEMI patients will receive standard clinical treatment and a single dose of placebo on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.

Drug: Placebo

Interventions

SGC001 DRUG

The single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.

SGC001

Placebo DRUG

The single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.

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:

• Male or female subjects aged 18\~75 years (both inclusive)
• Anterior STEMI, defined as: (a) Persistent chest pain or discomfort \> 30 minutes; AND (b) Persistent ST-segment elevation ≥0.1 mV in ≥2 contiguous precordial leads (V1-V6) on the admission ECG, with ≥0.2 mV required in leads V2 and V3; OR, if （a）clinical symptoms are atypical, (c) a positive point-of-care cardiac troponin test is required.
• Ability to receive study drug administration within 6 hours of symptom onset, as assessed by the investigator;
• Subjects who fully understand the purpose, nature, method, and potential adverse reactions of the trial, and who voluntarily sign the informed consent form and agree to participate in the study;

You may not qualify if:

• Individuals with the following medical histories:
• Myocardial infarction and coronary revascularization
• Cardiopulmonary resuscitation
• Stroke within 6 months before the first dose
• Aortic dissection
• Individuals who received thrombolytic therapy;
• Individuals who have recent febrile infection, requiring systemic treatment;
• Individuals with cardiogenic shock or hemodynamic instability (such as severe arrhythmia), including systolic blood pressure \<90 mmHg;
• Individuals with clear diagnosis of acute heart failure (Killip grade ≥ III, Killip grade is detailed in appendix);
• Individuals who cannot undergo cardiovascular magnetic resonance (CMR) testing or are known to be allergic to any radio-contrast agent;
• Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 1 months prior to receiving the investigational drug;
• Individuals with the following medical histories:
• severe liver and renal insufficiency;
• Patients with malignant tumors or previous history of malignant tumors;
• Severe autoimmune disease requiring therapeutic intervention;

Sponsors & Collaborators

• Beijing Sungen Biomedical Technology Co., Ltd: lead

Study Sites (4)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, 100013, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041099, China

Location

Teda International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

Location

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Wei Zhang, Bachelor

  The Second Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 29, 2025
• Study Start: January 20, 2025
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)