Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607380
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Randomized Open-Label Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-Label Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine Administered Alone and Simultaneously Administered in Chinese Healthy Subjects
Status:
COMPLETED
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 designed as a randomized open-label parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine
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