Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634927
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Pharmacokinetic Similarity Safety and Immunogenicity of Semaglutide Injection and Ozempic Injection in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 semaglutide injection or Ozempic injection 025mg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None