Ignite Creation Date:
2024-07-17 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469151
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-17
Brief Title:
A Study to Evaluate the Safety Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
Status:
RECRUITING
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 purpose of this study is to measure safety tolerability and pharmacokinetics PK of a single dose of AZD5148 administered via intravenous IV bolus or intramuscular IM injection in healthy participants
Detailed Description:
This is a first in human study which will be conducted at four clinical units Participants will be randomized to receive AZD5148 or placebo administered by intramuscular IM injection into the lateral thigh muscle or intravenous IV bolus single discrete dose of a drug
This study will include 7 dose cohorts two of which will include exclusively participants of Chinese descent Cohort 2b and 4b Each dose cohort will begin with a Sentinel Group of 2 participants randomized 11 AZD5148placebo The participants in the Sentinel Group will undergo a safety monitoring period of 24 hours before the remaining participants in that cohort are dosed If there would be no safety concerns the remaining participants in the cohort will be dosed in a 91 ratio AZD5148 placebo Each participant will be involved in the study for up to 56 weeks including Screening Period
The study will comprise
A Screening Period of maximum 28 days Day -28 to Day -1 inclusive
A Treatment and Follow-up Period lasting 12 months after the administration of the study drug
Participants will be resident at the Clinical Unit from the day before study drug administration Day -1 until all assessments are completed on Day 2
A final Follow-up Visit will occur within 361 14 days after the study drug administration
This study will include 7 dose cohorts two of which will include exclusively participants of Chinese descent Cohort 2b and 4b Each dose cohort will begin with a Sentinel Group of 2 participants randomized 11 AZD5148placebo The participants in the Sentinel Group will undergo a safety monitoring period of 24 hours before the remaining participants in that cohort are dosed If there would be no safety concerns the remaining participants in the cohort will be dosed in a 91 ratio AZD5148 placebo Each participant will be involved in the study for up to 56 weeks including Screening Period
The study will comprise
A Screening Period of maximum 28 days Day -28 to Day -1 inclusive
A Treatment and Follow-up Period lasting 12 months after the administration of the study drug
Participants will be resident at the Clinical Unit from the day before study drug administration Day -1 until all assessments are completed on Day 2
A final Follow-up Visit will occur within 361 14 days after the study drug administration
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