Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304961
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-03-05
Brief Title:
A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomised Single-dose Parallel Group Study in Healthy Volunteers to Assess the Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration
Status:
COMPLETED
Status Verified Date:
2024-09
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 study will assess the relative bioavailability between two dosage forms of tozorakimab test dosage form and reference dosage form and to assess the pharmacokinetic PK profiles of both dosage forms
Detailed Description:
This is a phase I randomised open-label single-dose single-centre parallel group study investigating the relative bioavailability of two dosage forms of tozorakimab test dosage form and reference dosage form
The study will comprise of
1 A screening period of 28 days
2 A Treatment period of 1 day
3 Ambulatory visits on scheduled days
c A final follow-up visit on Day 113 Week 16
The study will comprise of
1 A screening period of 28 days
2 A Treatment period of 1 day
3 Ambulatory visits on scheduled days
c A final follow-up visit on Day 113 Week 16
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