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

NCT06634927 · Completed

Last updated 2026-05-28

This clinical trial tested whether a new version of semaglutide injection works similarly to Ozempic® in healthy adults, while also checking for side effects and immune responses.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 68 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2024-09 · est. completion 2025-02

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06634927 ↗

Description as written by the study sponsor.

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.

Treatments tested

Ozempic® Drug

Participants will be given Ozempic ® injection 0.25mg abdominal subcutaneous injection.
HDG1901 Drug

Participants will be given HDG1901 injection 0.25mg abdominal subcutaneous injection.

Main thing measured	AUC0-inf
Sponsor	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06634927 ↗