Actively Recruiting
Phase 1 Evaluation of AZD4063 Injection for Adults with PLN R14del Dilated Cardiomyopathy Assessing Safety, Tolerability, and Drug Effects Across Single and Multiple Dose Groups
Led by AstraZeneca · Updated on 2026-07-16
31
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying AZD4063 in adults with phospholamban PLN R14del dilated cardiomyopathy to evaluate its safety, tolerability, and how the drug behaves in the body after single and multiple doses. This Phase 1, first-in-human, unblinded study includes groups receiving increasing doses to understand the effects and risks of AZD4063 in this specific heart condition. The study has two main parts single ascending dose SAD cohorts where participants receive one dose of AZD4063 by subcutaneous injection, and multiple ascending dose MAD cohorts where participants receive repeated doses. Optional additional groups may be added based on safety and drug behavior data from the initial cohorts. Each part includes a screening period, treatment with AZD4063 injections, and follow-up to monitor participants. Participants will undergo screening to confirm eligibility, then receive AZD4063 injections according to their assigned group. Throughout the study, researchers will monitor adverse events, measure drug levels in the blood, and evaluate effects on heart tissue and function through tests including echocardiography and biopsies. The study monitors participants for up to several months depending on the dose group, ensuring close safety and response tracking.
CONDITIONS
Brief Title
A Study of AZD4063 in PLN R14del Dilated Cardiomyopathy
Research Team
A
AstraZeneca Clinical Study Information Center
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