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Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
68
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI ≥50•Healthy volunteers
Primary endpoints
•AUC0-inf•AUC0-t•Cmax
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Participants must meet all of the following criteria to be enrolled in the study:
1. 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;
2. Healthy men and women, aged 18 to 55 years old (including);
3. Body mass index (BMI) 19.0~25.0 kg/m2 (including), weight ≥50.0 kg;
4. 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:
1. 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;
2. A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;
3. 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;
4. In the screening period, calcitonin was greater than the upper limit of normal;
5. Patients with HbA1c greater than 6.5% during the screening period;
6. 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;
7. 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;
8. Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 48 hours before check-in;
9. Known or suspected allergy to semaglutide injection or similar products and excipients;
10. Participants in clinical trials of any approved or unapproved investigational drug/device within 90 days prior to screening;
11. Pregnant and lactating female subjects;
12. Patients with difficulty in venous blood collection;
13. Those who were vaccinated within 4 weeks prior to screening or planned to be vaccinated during the trial;
14. 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;
15. Patients who have previously received Semaglutide injection or other GLP-1 or GLP-1/ GIP-like treatment;
16. Those who have a history of drug abuse or test positive for drug abuse screening;
17. Those who test positive for blood alcohol;
18. For any other reason, the investigator does not consider the volunteer to be suitable for participation in this clinical trial.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
9 endpointsAUC0-inf
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
AUC₀–∞
concentration, descriptive
AUC0-t
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
AUC₀–∞
concentration, descriptive
Cmax
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Cmax
concentration, descriptive
AUC_%Extrap
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
AUC₀–∞
concentration, descriptive
Tmax
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Tmax
descriptive
t 1/2
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Half-life
descriptive
λz
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
descriptive
CL
Time frame:-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
descriptive
Safety and Immunogenicity
Time frame:AEs will be collected after assigning the ICF. Immunogenicity sample will be collected at -60 minutes and 336、840 hours after administration.
descriptive
componentsTreatment-emergent AEs (any), Immunogenicity (ADA)
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.