A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants
Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
Participant must be between 18 and 55 years of age (inclusive), male or female.
Participant's body mass index (BMI) must be between 19 and 28 kg/m² (inclusive). The body weight should be ≥50 kg for men and ≥45 kg for women.
History or present history of clinically significant hematological, circulatory, respiratory, digestive, urinary, neurological, immune, endocrine, or psychiatric disorders, or other diseases that investigators believe may affect the safety of participants in the study.
History or evidence of any abnormal bleeding or coagulation disorders, or there may be coagulation dysfunction (such as Von Willebrand disease, hemophilia), long-term or unexplained clinically significant bleeding, or evidence of frequent unexplained bruising or thrombosis, or have a history of spontaneous bleeding, or diseases with increased risk of bleeding (such as active and meaningful peptic ulcers judged by investigators.
Individuals with a history of cardiovascular diseases, including but not limited to myocardial infarction, congenital heart disease, heart valve disease, coronary revascularization, angina, heart failure, and other heart diseases and arrhythmias that may cause QT prolongation; Or there may be other risk factors that lead to tip twisting ventricular tachycardia; Or there may be a history of atrial flutter, atrial fibrillation, or other conditions that may interfere with electrocardiogram measurements.
History of intolerance to SC injection or significant abdominal scars that may significantly affect the administration of the investigational drug or the assessment of local safety.
Parallel
YKYY033 Injection
Drugsubcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection
YKYY033 Placebo
Drugsubcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo
Adverse events(AEs)
Serious adverse events (SAEs)
Injection site reaction
Cmax（Peak plasma concentration）
AUC（Area under the plasma concentration versus time curve）
Tmax（Time to maximum plasma concentration）
T1/2（Half-Life）
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