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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Ozempic®; Drug: HDG1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT06634927

HDG1901-103

Details and patient eligibility

About

This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.

Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Experimental group

Experimental group

Description:

Experimental group: Semaglutide injection, specifications: 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous abdominal injection.

Treatment:

Drug: HDG1901

Active Comparator

Active Comparator group

Description:

Control group: Ozempic ® injection, 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous injection into the abdomen.

Treatment:

Drug: Ozempic®