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 range18 Years – 50 Years
SexALL
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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.
Exclusion criteria
✕. 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.
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 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.