Study identifier:D8330C00004
ClinicalTrials.gov identifier:NCT06611423
EudraCT identifier:N/A
CTIS identifier:2024-513143-82-00
A Phase Ib, Double-blind, Placebo-controlled, Randomised Trial Investigating the Effect of AZD3427 on Renal Perfusion in HFrEF Patients With Renal Impairment Using Positron Emission Tomography (PET)
Heart Failure with Reduced Ejection Fraction (HFrEF)
Phase 1
Yes
Dopamine
All
12
Interventional
20 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
Clinical Trial Consultants (CTC), Karolinska Institutet
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: IV Saline placebo followed by SC AZD3427 Participants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2). | Biological/Vaccine: AZD3427 AZD3427 SC injection to be prepared using AZD3427 diluent Other: Radiolabelled ligand Injection of radioligand for PET examinations Other: Saline Saline solution |
Placebo Comparator: IV Saline placebo followed by SC AZD3427 placebo Participants will receive IV administration of saline only placebo prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). | Other: AZD3427 Placebo AZD3427 Placebo Other: Radiolabelled ligand Injection of radioligand for PET examinations Other: Saline Saline solution |
Experimental: IV Dopamine diluted in saline followed by SC AZD3427 Participants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 on Day 1 (V2) | Biological/Vaccine: AZD3427 AZD3427 SC injection to be prepared using AZD3427 diluent Drug: Dopamine Dopamine Hydrochloride 50mg/5mL Other Name: Dopamine Other: Radiolabelled ligand Injection of radioligand for PET examinations |
Placebo Comparator: IV Dopamine diluted in saline followed by SC AZD3427 placebo Participants will receive IV administration of dopamine diluted in saline prior to a PET examination. This is followed by a single SC dose of AZD3427 Placebo on Day 1 (V2). | Other: AZD3427 Placebo AZD3427 Placebo Drug: Dopamine Dopamine Hydrochloride 50mg/5mL Other Name: Dopamine Other: Radiolabelled ligand Injection of radioligand for PET examinations |