Anterior Myocardial InfarctionPhase 1NCT07079618
A Research Study to Evaluate the Safety and Tolerability of SGC001 in Healthy Subjects
A Phase 1 study testing SGC001 in people with Anterior Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
Acute Myocardial Infarction (AMI) is an acute ischemic necrosis that occurs following acute stenosis or occlusion of the coronary arteries, and it is associated with a high morbidity and mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Myocardial Infarction
- What is being tested?
- SGC001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 15 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Healthy male or female subjects aged 18 ~ 50 years (both inclusive, based on the time of signing the informed consent form).
- Body mass index (BMI): 19.0 ~ 26.0 kg/m2 (both inclusive), body weight of male subjects ≥50.0 kg, and body weight of female subjects ≥45.0 kg.
- Female subjects of childbearing potential must agree to use effective contraception from screening until 3 months after receiving the investigational drug. In addition, they must agree to refrain from collecting or donating eggs during this period; their male partner of childbearing potential must also agree to use effective contraception during this period.
- Male subjects of childbearing potential must agree to use effective contraception and have no plans to conceive or donate sperm from screening until 3 months after receiving the investigational drug. During this period, their female partner of childbearing potential must also agree to use effective contraception.
Who cannot join
- Individuals with known allergy to therapeutic protein drugs or food or who may be allergic to the test drug or any component of the investigational drug, based on the investigator's judgment.
- Individuals with a history of cardiovascular disease.
- Individuals with a history of acute or chronic bronchospasm, including treated or untreated asthma, and chronic obstructive pulmonary disease (COPD).
- Individuals with a history of autoimmune disease.
- Individuals with a history of malignant tumors.
- Individuals with clinically significant abnormalities on physical examination, vital signs examination, electrocardiogram or laboratory tests, as judged by the clinician.
Show all 21Show fewer
- Individuals with a history of drug abuse within the past 5 years, the presence of drug abuse within 3 months before the study, or a positive drug abuse screening result.
- Individuals who have smoked within 3 months before screening (consuming ≥ 5 cigarettes per day) or habitual use of nicotine containing products.
- Individuals who have consumed more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% of alcohol content or 150 mL of wine) within 3 months prior to screening, or who consume alcohol-containing products within 48 hours before dosing, or who have a positive alcohol breath test result at screening and/or D-1.
- Individuals who have received monoclonal antibody or biologic therapy within 3 months prior to receiving the investigational drug.
- Individuals who have received medications that may affect the immune system (e.g., immunosuppressants, cytokines and cytokine inducers,) within 3 months prior to receiving the investigational drug.
- Individuals who have received anticoagulant or antiplatelet medications within 28 days prior to receiving the investigational drug.
- Individuals who have received any vaccine within 28 days prior to receiving the investigational drug, or who plan to receive a vaccine during the trial period.
- Individuals who have suffered from clinically significant major diseases or undergone major surgical procedures within 28 days prior to receiving the investigational drug, or who anticipate requiring major surgery during the trial period.
- Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to receiving the investigational drug or within the 5 half-lives of the drug (whichever is longer).
- Individuals whose screening viral serology tests are positive for human immunodeficiency virus antigen/antibodies (HIV-Ag/Ab), hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV-Ab), or antibodies to Treponema pallidum (TP-Ab).
- Individuals who have difficulty in venous blood collection or have a history of needle and blood fainting.
- Women who have positive result in pregnancy test or are breastfeeding at Screening or D-1.
- Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 3 months prior to receiving the investigational drug.
- Individuals who have history of blood donation or massive blood loss (≥ 400 mL) within 3 months prior to screening.
- Any other circumstance that, in the judgement of the investigator, may affect the ability of the subject to provide informed consent or to follow the trial protocol, or where the subject's participation in the trial may affect the outcome of the trial or his/her safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, 100013
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Pharmacodynamics Profile, and Immunogenicity of SGC001 in Healthy Adult Subjects
Acute Myocardial Infarction (AMI) is an acute ischemic necrosis that occurs following acute stenosis or occlusion of the coronary arteries, and it is associated with a high morbidity and mortality rate. Acute myocardial infarction typically occurs in middle-aged and elderly individuals, according to the American Heart Association, with the average age of first occurrence being 65.1 years for men and 72.0 years for women. Myocardial infarction (MI) has a significant impact on global health, affecting over 7 million people worldwide annually. In addition, MI can impose a substantial economic burden on society and families. The research study is a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Pharmacodynamics Profile, and Immunogenicity of SGC001 in Healthy Adult Subjects
- Conditions
- Anterior Myocardial Infarction
- Being tested
- SGC001, Placebo
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGC001Drug
In this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug SGC001 should be administered once via intravenous injection within 6 hours and the administration time 10 minutes.
PlaceboDrug
In this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug placebo should be administered once via intravenous injection within 6 hours and the administration time 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| SGC001 | Experimental | Administration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. Receives: Drug: SGC001 |
| Placebo | Placebo comparator | Administration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Adverse events (AEs)
Measured: From randomisation to end-of-study (up to 57 days)
Serious adverse events (SAEs)
Serious adverse events (SAEs)
Measured: From randomisation to end-of-study (up to 57 days)
ECG QT Interval
ECG QT Interval
Measured: From randomisation to end-of-study (up to 57 days)
Number of participants with Laboratory tests
hematology, blood chemistry, urinalysis, and coagulation
Measured: From randomisation to end-of-study (up to 57 days)
Secondary outcomes (11)
Maximum Concentration (Cmax)
Maximum Concentration (Cmax)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Time to maximum concentration (Tmax)
time to maximum concentration (Tmax)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Area under the plasma concentration-time curve from time 0 to the last quantifiable time point postdose (AUC0-t)
Area under the plasma concentration-time curve from time 0 to the last quantifiable time point postdose (AUC0-t)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Elimination half-life (t1/2)
Elimination half-life (t1/2)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Elimination rate constant (λz)
Elimination rate constant (λz)
Measured: Day 1-Day 4, Day 6, Day 8-Day 57
Interleukin-6(IL-6) [PD endpoints]
Interleukin-6(IL-6)
Measured: Day 1-Day 2,Day 4,Day 8-Day 22
Tumor necrosis factor-α（TNF-α)[PD endpoints]
Tumor necrosis factor-α（TNF-α)
Measured: Day 1-Day 2,Day 4,Day 8-Day 22
Immunoglobulin G (IgG)[PD endpoints]
Immunoglobulin G (IgG)
Measured: Day 1-Day 2,Day 4,Day 8-Day 22
Interleukin-1 β (IL-1 β)[PD endpoints]
Interleukin-1 β (IL-1 β)
Measured: Day 1-Day 2,Day 4,Day 8-Day 22
Qualitative detection of anti-drug antibodies in serum（Anti-drug antibody (ADA)）
Qualitative detection of anti-drug antibodies in serum, followed by calculation of the positivity rate as the number of positive samples divided by the total number of samples
Measured: Day 1,Day 8-Day 15,Day 29-Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start20 Aug 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Lin, Ph.D, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079618
- Sponsor's protocol ID
- SG-SGC001-101
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data(IPD) will be shared if necessary
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Pharmacodynamics Profile, and Immunogenicity of SGC001 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07079618
- Acronym / sponsor ID
- SG-SGC001-101
- Conditions
- Anterior Myocardial Infarction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Myocardial Infarction (AMI) is an acute ischemic necrosis that occurs following acute stenosis or occlusion of the coronary arteries, and it is associated with a high morbidity and mortality rate. Acute myocardial infarction typically occurs in middle-aged and elderly individuals, according to the American Heart Association, with the average age of first occurrence being 65.1 years for men and 72.0 years for women. Myocardial infarction (MI) has a significant impact on global health, affecting over 7 million people worldwide annually. In addition, MI can impose a substantial economic burden on society and families. The research study is a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Pharmacodynamics Profile, and Immunogenicity of SGC001 in Healthy Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGC001 | Experimental | Drug: SGC001Administration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration should be initiated as early as possible, with a single intravenous injection completed within 6 hours of disease onset. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Healthy male or female subjects aged 18 ~ 50 years (both inclusive, based on the time of signing the informed consent form).
- Body mass index (BMI): 19.0 ~ 26.0 kg/m2 (both inclusive), body weight of male subjects ≥50.0 kg, and body weight of female subjects ≥45.0 kg.
- Female subjects of childbearing potential must agree to use effective contraception from screening until 3 months after receiving the investigational drug. In addition, they must agree to refrain from collecting or donating eggs during this period; their male partner of childbearing potential must also agree to use effective contraception during this period.
- Male subjects of childbearing potential must agree to use effective contraception and have no plans to conceive or donate sperm from screening until 3 months after receiving the investigational drug. During this period, their female partner of childbearing potential must also agree to use effective contraception.
Key exclusion criteria (21 listed)
- Individuals with known allergy to therapeutic protein drugs or food or who may be allergic to the test drug or any component of the investigational drug, based on the investigator's judgment.
- Individuals with a history of cardiovascular disease.
- Individuals with a history of acute or chronic bronchospasm, including treated or untreated asthma, and chronic obstructive pulmonary disease (COPD).
- Individuals with a history of autoimmune disease.
- Individuals with a history of malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGC001In this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug SGC001 should be administered once via intravenous injection within 6 hours and the administration time 10 minutes. | Drug | SGC001 |
| PlaceboIn this study, 6 dose groups are planned. 8 subjects are enrolled in each group. A total of 48 subjects will be enrolled. The administration method for each group is as follows: The drug placebo should be administered once via intravenous injection within 6 hours and the administration time 10 minutes. | Drug | Placebo |
Primary outcome
Adverse events (AEs)
Time frame: From randomisation to end-of-study (up to 57 days)
Adverse events (AEs)
Serious adverse events (SAEs)
Time frame: From randomisation to end-of-study (up to 57 days)
Serious adverse events (SAEs)
ECG QT Interval
Time frame: From randomisation to end-of-study (up to 57 days)
ECG QT Interval
Number of participants with Laboratory tests
Time frame: From randomisation to end-of-study (up to 57 days)
hematology, blood chemistry, urinalysis, and coagulation
11 secondary outcomes
Maximum Concentration (Cmax)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Time to maximum concentration (Tmax)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Area under the plasma concentration-time curve from time 0 to the last quantifiable time point postdose (AUC0-t)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Elimination half-life (t1/2)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Elimination rate constant (λz)
Time frame: Day 1-Day 4, Day 6, Day 8-Day 57
Interleukin-6(IL-6) [PD endpoints]
Time frame: Day 1-Day 2,Day 4,Day 8-Day 22
Tumor necrosis factor-α（TNF-α)[PD endpoints]
Time frame: Day 1-Day 2,Day 4,Day 8-Day 22
Immunoglobulin G (IgG)[PD endpoints]
Time frame: Day 1-Day 2,Day 4,Day 8-Day 22
Interleukin-1 β (IL-1 β)[PD endpoints]
Time frame: Day 1-Day 2,Day 4,Day 8-Day 22
Qualitative detection of anti-drug antibodies in serum（Anti-drug antibody (ADA)）
Time frame: Day 1,Day 8-Day 15,Day 29-Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data(IPD) will be shared if necessary
Related trials for Anterior Myocardial Infarction
Recruiting
Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction
Intravascular Imaging and Microvascular Obstruction
Not yet recruiting
Prophylactic IABP in Delayed-Presentation Anterior STEMI
Acute Anterior ST-Segment Elevation Myocardial Infarction
RecruitingPhase 2
Rituximab in Patients With ST-elevation Myocardial Infarction
ST Elevated Myocardial Infarction
Active, not recruiting
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
Left Ventricular Dysfunction, Coronary Artery Disease
RecruitingPhase 2
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
Acute Anterior ST-Segment Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Lin, Ph.D principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGC001 in people with Anterior Myocardial Infarction, run by Beijing Sungen Biomedical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From randomisation to end-of-study (up to 57 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.