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

Last updated: October 8, 2024
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Ozempic®

HDG1901

Clinical Study ID

NCT06634927
HDG1901-103
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 andable, in the investigator's judgment, to comply with all experimentalrequirements 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), clinicallaboratory examination, no clinically significant abnormalities;

Exclusion

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 clinicallysignificant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal,hematological, respiratory, cutaneous, neurological, gynecological, psychiatric orother disease;

  2. A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2Aor 2B syndrome, or related family history; Or other malignant tumor history;

  3. Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladderhistory, pancreatic injury history and other high-risk factors that may lead topancreatitis;

  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 andthose 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, orwho cannot abstain from alcohol during the test period;

  8. Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (suchas coffee, strong tea, chocolate, etc.) within 48 hours before check-in;

  9. Known or suspected allergy to semaglutide injection or similar products andexcipients;

  10. Participants in clinical trials of any approved or unapproved investigationaldrug/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 bevaccinated during the trial;

  14. 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;

  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 besuitable for participation in this clinical trial.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Ozempic®
Phase: 1
Study Start date:
September 20, 2024
Estimated Completion Date:
February 10, 2025

Connect with a study center

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Active - Recruiting

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