Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828343
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2021-03-30
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Randomized Participant-Blind Investigator-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of a single subcutaneous SC dose of rozanolixizumab administered to healthy participants by manual push MP versus vs syringe driver
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None