Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus Types I And Ii
Treatment
Ozempic®
HDG1901
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 andable, in the investigator's judgment, to comply with all experimentalrequirements 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), clinicallaboratory examination, no clinically significant abnormalities;
Exclusion
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded:
Have a history of clinically serious disease or currently have any clinicallysignificant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal,hematological, respiratory, cutaneous, neurological, gynecological, psychiatric orother disease;
A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2Aor 2B syndrome, or related family history; Or other malignant tumor history;
Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladderhistory, pancreatic injury history and other high-risk factors that may lead topancreatitis;
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 andthose who could not smoke during the whole test period;
Those who have a history of alcohol abuse in the six months prior to screening, orwho cannot abstain from alcohol during the test period;
Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (suchas coffee, strong tea, chocolate, etc.) within 48 hours before check-in;
Known or suspected allergy to semaglutide injection or similar products andexcipients;
Participants in clinical trials of any approved or unapproved investigationaldrug/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 bevaccinated during the trial;
People who donate blood or lose more than 400 mL of blood or receive bloodtransfusions 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 besuitable for participation in this clinical trial.
Study Design
Connect with a study center
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
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