NCT06634927

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Ozempic®	Participants will be given Ozempic ® injection 0.25mg abdominal subcutaneous injection.
DRUG	HDG1901	Participants will be given HDG1901 injection 0.25mg abdominal subcutaneous injection.

Timeline

• Start date: 2024-09-22
• Primary completion: 2024-11-14
• Completion: 2025-02-12
• First posted: 2024-10-10
• Last updated: 2025-08-01

Locations

1 site across 1 country: China