Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556641
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Clinical Study of GZR33 and GZR101 in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase Ib Clinical Study on the Safety Tolerance Pharmacokinetics and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-08
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 evaluates the safety tolerability pharmacokinetics and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjectsThis study consists of Part A and Part B
Part A is a randomized open-label single-dose two-sequence two-period cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection
Part B is a randomized double-blind placebo-controlled multiple-dose parallel-group design study evaluating the safety tolerability immunogenicity and PK of GZR33 and GZR101
Part A is a randomized open-label single-dose two-sequence two-period cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection
Part B is a randomized double-blind placebo-controlled multiple-dose parallel-group design study evaluating the safety tolerability immunogenicity and PK of GZR33 and GZR101
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