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AZD4063 · 1 trial · 1 indication
The safety and tolerability of AZD4063 following the SC administration of single doses in participants with PLN R14del dilated cardiomyopathy will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (SAD): Dose 1 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 1 of AZD4063 via SC injection in Cohort 1 of SAD. |
| Cohort 2 (SAD): Dose 2 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 2 of AZD4063 via SC injection in Cohort 2 of SAD. |
| Cohort 3 (SAD): Dose 3 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 3 of AZD4063 via SC injection in Cohort 3 of SAD. |
| Cohort 4 (SAD): Dose 4 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 4 of AZD4063 via SC injection in Cohort 4 of SAD. |
| Optional Cohort 1 (SAD): Dose 5 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 5 of AZD4063 via SC injection in the optional cohort of the study. This additional cohort will be added depending on the findings. |
| Optional Cohort 2 (SAD): Dose 6 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 6 of AZD4063 via SC injection in the optional cohort of the study. This additional cohort will be added depending on the findings. |
| Optional Cohort 3 (SAD): Dose 7 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 7 of AZD4063 via SC injection in the optional cohort of the study. This additional cohort will be added depending on the findings. |
| Optional Cohort 4 (SAD): Dose 8 of AZD4063 | EXPERIMENTAL | Participants will receive Dose 8 of AZD4063 via SC injection in the optional cohort of the study. This additional cohort will be added depending on the findings. |
| Name | Type | Description |
|---|---|---|
| AZD4063 | DRUG | AZD4063 will be administered as solution for injection via subcutaneous route of administration. |
Inclusion Criteria: * Participants must be 18 to 80 years of age inclusive, at the time of Screening * Participants with pre-existing positive screening for R14 del PLN mutation * Participants with screening Left ventricular eject fraction ≤ 45% as assessed by echocardiography * Participants with N...
AZD4063 is an investigational small molecule being developed for the treatment of Dilated Cardiomyopathy, specifically in patients with the PLN R14del mutation. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
AZD4063 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
AZD4063 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied in a clinical trial for Dilated Cardiomyopathy.
AZD4063 is being studied in a Phase 1 clinical trial with the identifier NCT07241104, titled 'A Study of AZD4063 in PLN R14del Dilated Cardiomyopathy'. This trial is currently recruiting participants in the Netherlands and aims to enroll approximately 23 patients.
AZD4063 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied under this identifier in clinical trials for Dilated Cardiomyopathy.