Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555822
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Randomized Single-blind Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of AZD5004 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The main purpose of this study is to assess the safety tolerability and pharmacokinetic PK of AZD5004 administered as multiple oral doses in healthy participants
Detailed Description:
This is a placebo-controlled study to assess the safety efficacy tolerability and PK of repeated dosing of AZD5004 compared with placebo
Participants who are eligible according to the inclusionexclusion criteria will be randomized to receive AZD5004 or matching placebo
The study will comprise
1 A Screening Period of maximum 28 days
2 A Treatment Period of 106 days
3 A final Follow-up Visit approximately 14 days after the last study intervention administration
Participants who are eligible according to the inclusionexclusion criteria will be randomized to receive AZD5004 or matching placebo
The study will comprise
1 A Screening Period of maximum 28 days
2 A Treatment Period of 106 days
3 A final Follow-up Visit approximately 14 days after the last study intervention administration
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