Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-08
Brief Title:
A Study to Assess the Safety Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Randomized Single-Blind Placebo-Controlled Study to Assess the Safety Tolerability And Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Participants
Status:
ACTIVE_NOT_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 will assess the safety tolerability and pharmacokinetics PK of AZD0292 following intravenous IV administration of single ascending doses to healthy adult participants
Detailed Description:
This is a First-time-in-human FTiH trial
Eligible participants will be randomized to receive AZD0292 or Placebo Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention
The study will comprise
1 A Screening Period of maximum 28 days
2 A Treatment Period
3 A Follow-up Period from Day 3 to Day 16
4 An extended Follow-up Period from Day 17 to Day 61
Participants will be involved in this study for a maximum duration of 13 weeks
Eligible participants will be randomized to receive AZD0292 or Placebo Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention
The study will comprise
1 A Screening Period of maximum 28 days
2 A Treatment Period
3 A Follow-up Period from Day 3 to Day 16
4 An extended Follow-up Period from Day 17 to Day 61
Participants will be involved in this study for a maximum duration of 13 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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