Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630067
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2020-10-27
Brief Title:
Assessment of Safety Tolerability Immunogenicity and Pharmacokinetics of AZD3427
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase Iab Randomized Single-blinded Placebo-controlled Study to Evaluate the Safety Tolerability Immunogenicity and Pharmacokinetics of Single Ascending Doses of AZD3427 in Healthy Volunteers and Multiple Ascending Doses of AZD3427 in Patients With Heart Failure HFrEF and HF With EF 41
Status:
COMPLETED
Status Verified Date:
2022-10
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:
This first-time-in-human FTIH study will be conducted to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and immunogenicity of single doses of AZD3427 in healthy volunteers and multiple doses of AZD3427 in patients with heart failure HF
Detailed Description:
This is a multi-center single and multiple ascending dose study SAD and MAD
Part A SAD will include 7 cohorts 8 healthy volunteers in each cohort and will randomize to AZD3427 or placebo in a 62 ratio One cohort will entirely include participants of Japanese descent
Part B MAD will include 6 cohorts 8 heart failure patients in each cohort and will randomize to AZD3427 or placebo in a 62 ratio Of these 3 cohorts will contain participants with heart failure with reduced ejection fraction HFrEF and the other 3 cohorts will comprise of participants with heart failure with HF with ejection fraction EF 41 There will be a maximum screening period of 27 days Participants in part A and B will undergo study drug administration on Day 1 In addition participants in part B will return for 4 additional doses on Days 8 15 22 and 29 Participants will be followed for at least 50 days after the last dose of study drug
Part A SAD will include 7 cohorts 8 healthy volunteers in each cohort and will randomize to AZD3427 or placebo in a 62 ratio One cohort will entirely include participants of Japanese descent
Part B MAD will include 6 cohorts 8 heart failure patients in each cohort and will randomize to AZD3427 or placebo in a 62 ratio Of these 3 cohorts will contain participants with heart failure with reduced ejection fraction HFrEF and the other 3 cohorts will comprise of participants with heart failure with HF with ejection fraction EF 41 There will be a maximum screening period of 27 days Participants in part A and B will undergo study drug administration on Day 1 In addition participants in part B will return for 4 additional doses on Days 8 15 22 and 29 Participants will be followed for at least 50 days after the last dose of study drug
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