A Research Study to Evaluate the Safety and Tolerability of SGC001 in Healthy Subjects (NCT07079618) | Clinical Trial Compass
CompletedPhase 1
A Research Study to Evaluate the Safety and Tolerability of SGC001 in Healthy Subjects
China49 participantsStarted 2024-08-20
Plain-language 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. 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
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AEs)
Timeframe: From randomisation to end-of-study (up to 57 days)
2
Serious adverse events (SAEs)
Timeframe: From randomisation to end-of-study (up to 57 days)
3
ECG QT Interval
Timeframe: From randomisation to end-of-study (up to 57 days)
4
Number of participants with Laboratory tests
Timeframe: From randomisation to end-of-study (up to 57 days)
. 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.
. 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.