Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT07241104
Brief Summary:
The purpose of the study is to assess the safety, tolerability and the pharmacokinetics (PK) of AZD4063 after single and multiple dose administration in participants with phospholamban (PLN) R14del dilated cardiomyopathy.
Detailed Description:
This is a Phase 1, first in human, unblinded, ascending dose study which will be comprised of: 3 single ascending dose (SAD) cohorts, 3 multiple ascending dose (MAD) cohorts and optional cohorts.
The SAD part of the study will assess the single doses of AZD4063 across 3 cohorts. It will consist of:
* A screening period
* A treatment period: The participants will receive a single dose of AZD4063 by subcutaneous (SC) injection
* A follow-up period
The MAD part of the study will initiate on receiving the data from SAD cohort with available safety, PK and pharmacodynamics (PD) data from all cohorts. This part of the study will consist of:
* A screening period
* A treatment period: The participants will receive multiple doses of AZD4063 by SC injection
* A follow-up period
Optional cohorts may be added based on emerging safety, PK and PD data of the SAD and MAD cohorts.
Study:
NCT07241104
Study Brief:
Protocol Section:
NCT07241104