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AZD3427 for Heart Failure

Phase 1
Waitlist Available
Led By Ronald Goldwater, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 5, 8, 15, 29, and day 50 or e/t ; part b: day 1 (pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 32, 57, 71 and 78 or e/t

Summary

This trial tests a new drug, AZD3427, to see if it is safe and how it behaves in the body. It involves healthy volunteers and heart failure patients. The goal is to understand its safety and effects.

Eligible Conditions
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 5, 8, 15, 29, and day 50 or e/t ; part b: day 1 (pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 32, 57, 71 and 78 or e/t
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 5, 8, 15, 29, and day 50 or e/t ; part b: day 1 (pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 32, 57, 71 and 78 or e/t for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Adverse Events and Serious Adverse Events
Secondary study objectives
Area Under Serum Concentration-time Curve From Zero to Infinity (AUCinf)
Area Under the Serum Concentration-time Curve from Zero to 168 Hours Post-dose Administration (AUC0-168)
Area Under the Serum Concentration-time Curve from Zero to the Last Quantifiable Concentration (AUClast)
+5 more

Trial Design

15Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD3427: Cohort 7aExperimental Treatment1 Intervention
Participants will receive single SC dose F of AZD3427 on Day 1
Group II: AZD3427: Cohort 6bExperimental Treatment1 Intervention
Participants with HF with EF ≥ 41% will receive SC dose C of AZD3427 on Days 1, 8, 15, 22, and 29.
Group III: AZD3427: Cohort 6aExperimental Treatment1 Intervention
Participants of Japanese descent will receive single SC dose anticipated equal to the highest dose of AZD3427 in the global cohorts on Day 1.
Group IV: AZD3427: Cohort 5bExperimental Treatment1 Intervention
Participants with HFrEF will receive SC dose C of AZD3427 on Days 1, 8, 15, 22, and 29.
Group V: AZD3427: Cohort 5aExperimental Treatment1 Intervention
Participants will receive single IV dose E of AZD3427 on Day 1.
Group VI: AZD3427: Cohort 4bExperimental Treatment1 Intervention
Participants with HF with EF ≥ 41% will receive SC dose B of AZD3427 on Days 1, 8, 15, 22, and 29.
Group VII: AZD3427: Cohort 4aExperimental Treatment1 Intervention
Participants will receive single SC dose D of AZD3427 on Day 1.
Group VIII: AZD3427: Cohort 3bExperimental Treatment1 Intervention
Participants with HFrEF will receive SC dose B of AZD3427 on Days 1, 8, 15, 22, and 29.
Group IX: AZD3427: Cohort 3aExperimental Treatment1 Intervention
Participants will receive single SC dose C of AZD3427 on Day 1.
Group X: AZD3427: Cohort 2bExperimental Treatment1 Intervention
Participants with HF with EF ≥ 41% will receive SC dose A of AZD3427 on Days 1, 8, 15, 22, and 29.
Group XI: AZD3427: Cohort 2aExperimental Treatment1 Intervention
Participants will receive single SC dose B of AZD3427 on Day 1.
Group XII: AZD3427: Cohort 1bExperimental Treatment1 Intervention
Participants with HFrEF will receive SC dose A of AZD3427 on Days 1, 8, 15, 22, and 29.
Group XIII: AZD3427: Cohort 1aExperimental Treatment1 Intervention
Participants will receive single SC dose A of AZD3427 on Day 1.
Group XIV: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive single SC or IV dose of placebo matched to AZD3427 on Day 1.
Group XV: Part B: PlaceboPlacebo Group1 Intervention
Participants with HFrEF or HF with EF ≥ 41% will receive SC dose of placebo matched to AZD3427 on Days 1, 8, 15, 22, and 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD3427
2020
Completed Phase 1
~110

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,668 Total Patients Enrolled
87 Trials studying Heart Failure
161,804 Patients Enrolled for Heart Failure
Ronald Goldwater, MDPrincipal InvestigatorParexel Early Phase Clinical Unit (Baltimore), Harbor Hospital, 3001 S. Hanover St., Baltimore, MD 21225, United States of America (USA)
13 Previous Clinical Trials
502 Total Patients Enrolled
David Lanfear, MDPrincipal InvestigatorHenry Ford Hospital, USA, MI
1 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Heart Failure
400 Patients Enrolled for Heart Failure
~21 spots leftby Nov 2025
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