Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

Inclusion criteria

Participants must meet all of the following criteria to be enrolled in the study:

• Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator's judgment, to comply with all experimental requirements and restrictions;
• Healthy men and women, aged 18 to 55 years old (including);
• Body mass index (BMI) 19.0~25.0 kg/m2 (including), weight ≥50.0 kg;
• Physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory examination, no clinically significant abnormalities;

Exclusion criteria

Subjects who meet any of the following criteria will be excluded:

• Have a history of clinically serious disease or currently have any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, hematological, respiratory, cutaneous, neurological, gynecological, psychiatric or other disease;
• A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;
• Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history, pancreatic injury history and other high-risk factors that may lead to pancreatitis;
• In the screening period, calcitonin was greater than the upper limit of normal;
• Patients with HbA1c greater than 6.5% during the screening period;
• Those who smoked more than 5 cigarettes per day in the 3 months before screening and those who could not smoke during the whole test period;
• Those who have a history of alcohol abuse in the six months prior to screening, or who cannot abstain from alcohol during the test period;
• Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 48 hours before check-in;
• Known or suspected allergy to semaglutide injection or similar products and excipients;
• Participants in clinical trials of any approved or unapproved investigational drug/device within 90 days prior to screening;
• Pregnant and lactating female subjects;
• Patients with difficulty in venous blood collection;
• Those who were vaccinated within 4 weeks prior to screening or planned to be vaccinated during the trial;
• People who donate blood or lose more than 400 mL of blood or receive blood transfusions or use blood products in the 3 months prior to screening;
• Patients who have previously received Semaglutide injection or other GLP-1 or GLP-1/ GIP-like treatment;
• Those who have a history of drug abuse or test positive for drug abuse screening;
• Those who test positive for blood alcohol;
• For any other reason, the investigator does not consider the volunteer to be suitable for participation in this clinical trial.