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AZD3427 · 2 trials · 2 indications
To evaluate the effect of AZD3427 on PVR parameter compared with placebo as measured by right heart catheterization (RHC) after 24 weeks of treatment in participants with HF and PH Group 2.
Assessment of the safety and tolerability of single and multiple ascending doses of AZD3427.
| Arm | Type | Description |
|---|---|---|
| AZD3427 Dose A | EXPERIMENTAL | The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155. |
| AZD3427 Dose B | EXPERIMENTAL | The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155. |
| AZD3427 Dose C | EXPERIMENTAL | The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155. |
| Placebo | PLACEBO_COMPARATOR | The participants will receive single dose of placebo every 2 weeks for 24 weeks from Day 1 to Day 155. |
| AZD3427: Cohort 1a | EXPERIMENTAL | Participants will receive single SC dose A of AZD3427 on Day 1. |
| AZD3427: Cohort 2a | EXPERIMENTAL | Participants will receive single SC dose B of AZD3427 on Day 1. |
| AZD3427: Cohort 3a | EXPERIMENTAL | Participants will receive single SC dose C of AZD3427 on Day 1. |
| AZD3427: Cohort 4a | EXPERIMENTAL | Participants will receive single SC dose D of AZD3427 on Day 1. |
| AZD3427: Cohort 5a | EXPERIMENTAL | Participants will receive single IV dose E of AZD3427 on Day 1. |
| AZD3427: Cohort 6a | EXPERIMENTAL | Participants of Japanese descent will receive single SC dose anticipated equal to the highest dose of AZD3427 in the global cohorts on Day 1. |
| AZD3427: Cohort 7a | EXPERIMENTAL | Participants will receive single SC dose F of AZD3427 on Day 1 |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will receive single SC or IV dose of placebo matched to AZD3427 on Day 1. |
| AZD3427: Cohort 1b | EXPERIMENTAL | Participants with HFrEF will receive SC dose A of AZD3427 on Days 1, 8, 15, 22, and 29. |
| AZD3427: Cohort 2b | EXPERIMENTAL | Participants with HF with EF ≥ 41% will receive SC dose A of AZD3427 on Days 1, 8, 15, 22, and 29. |
| AZD3427: Cohort 3b | EXPERIMENTAL | Participants with HFrEF will receive SC dose B of AZD3427 on Days 1, 8, 15, 22, and 29. |
| AZD3427: Cohort 4b | EXPERIMENTAL | Participants with HF with EF ≥ 41% will receive SC dose B of AZD3427 on Days 1, 8, 15, 22, and 29. |
| AZD3427: Cohort 5b | EXPERIMENTAL | Participants with HFrEF will receive SC dose C of AZD3427 on Days 1, 8, 15, 22, and 29. |
| AZD3427: Cohort 6b | EXPERIMENTAL | Participants with HF with EF ≥ 41% will receive SC dose C of AZD3427 on Days 1, 8, 15, 22, and 29. |
| Part B: Placebo | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| AZD3427 | DRUG | The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks. |
| Placebo | DRUG | The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks. |
Inclusion criteria: 1. Participant must be ≥ 18 years of age inclusive. 2. Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-L...
AZD3427 is an investigational small molecule being developed for pulmonary hypertension (World Health Organization Group 2) and heart failure. It is being studied in patients with heart failure and pulmonary hypertension Group 2, a condition where elevated pressure in the lungs is associated with left heart disease.
AZD3427 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug in cardiovascular indications.
AZD3427 is in clinical development. A Phase 1 trial has been completed, and a Phase 2 study in participants with heart failure and pulmonary hypertension Group 2 has also been completed. The drug is investigational and has not been approved by regulatory authorities.
AZD3427 has been studied in two clinical trials. NCT04630067 was a Phase 1 study assessing safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers with heart failure. NCT05737940 was a Phase 2 study in participants with heart failure and pulmonary hypertension Group 2, conducted across multiple countries.
AZD3427 is the only name provided for this investigational drug. No alternative names or brand names have been associated with this compound in the available clinical trial information. It is identified solely by its development code AZD3427.