Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7594 · 5 trials · 6 indications
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To estimate the relative bioavailability of AZD7594 following inhalation via nebulizer Omron NE C900-E (2 dose levels) and via DPI SD3FL
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
To assess the safety and tolerability of single and multiple doses of AZD7594
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
No statistical tests will be performed
| Arm | Type | Description |
|---|---|---|
| AZD7594 0.7 mg | EXPERIMENTAL | The study subjects will receive AZD7594 via nebulizer, during 8 minutes: 0.7 mg, delivered dose 1 inhalation |
| AZD7594 1.6 mg | EXPERIMENTAL | The study subjects will receive AZD7594 via nebulizer, during 8 minutes: 1.6 mg, delivered dose 1 inhalation |
| AZD7594 720 μg | ACTIVE_COMPARATOR | The study subjects will receive AZD7594 via DPI: 0.72 mg, delivered dose (792 µg nominal dose) 1 inhalation |
| Cohort 1 | EXPERIMENTAL | The study will include adolescent patients of 12 to 17 years of age, with subgroups of 12-14 years age and 15-17 years age. |
| Cohort 2 | EXPERIMENTAL | AZD7594 inhalation powder (400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) |
| Cohort 3 | EXPERIMENTAL | 1600 μg AZD7594 inhalation powder (4 x 400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) |
| Cohort 4 | EXPERIMENTAL | 400 μg AZD7594 pressurized inhalation suspension (2 x 200 μg inhalations) or placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI) |
| Treatment sequence 1 | EXPERIMENTAL | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
| Treatment sequence 2 | EXPERIMENTAL | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
| 1 | EXPERIMENTAL | Subjects will participate in 1 of up to 9 groups in Part A (single ascending dose part) or 1 of 4 groups in Part B (multiple ascending dose part). Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B. |
| 2 | PLACEBO_COMPARATOR | Subjects will participate in 1 of up to 9 groups in Part A or 1 of 4 groups in Part B. Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B. |
| Name | Type | Description |
|---|---|---|
| AZD7594 | DRUG | Treatment A: The study drug is a nebulizer suspension with strength 2.8 mg/mL using 2 mL in the device. The study drug is administered via oral inhalation. Treatment B: The study drug is a nebulizer suspension with strength 6.3 mg/mL using 2 mL in the device. The study drug was administered via oral inhalation. Treatment C: The study drug is an inhalation powder. The study drug was administered via oral inhalation. |
| AZD7594 inhalation powder (200 μg) | DRUG | 200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI) |
| AZD7594 inhalation powder (400 μg) | DRUG | Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI |
| AZD7594 pressurized inhalation suspension (200 μg) | DRUG | 400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI) |
| AZD7594 placebo inhalation powder | DRUG | AZD7594 placebo inhalation powder via multi-dose DPI |
| AZD7594 placebo pressurized inhalation suspension | DRUG | AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI) |
| AZD7594 Solution for infusion (150 μg intravenous formulation) | DRUG | Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV |
| AZD7594 Oral suspension (1200 μg oral formulation) | DRUG | 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral |
| AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) | DRUG | Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler) |
| AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) | DRUG | Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI) |
| AZD7594 Pressurized inhalation suspension (400 μg) by pMDI | DRUG | Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg |
| Placebo to match | DRUG | Matching placebo inhaled via Spira nebuliser |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and female subjects aged 18 - 55 years (inclusive) at Screening with suitable veins for cannulation or repeated venepuncture. 3. Females must have a negative pregna...
AZD7594 is an investigational small molecule being developed for respiratory conditions including asthma and chronic obstructive pulmonary disease (COPD). It is administered via inhalation and is currently in Phase 1 clinical development. The drug is not yet approved and remains under study for safety and pharmacokinetic evaluation.
AZD7594 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and patients with asthma.
AZD7594 is in Phase 1 clinical development. All four completed trials for this drug are Phase 1 studies, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval for any indication.
AZD7594 has completed four Phase 1 clinical trials. These include NCT02645253 in healthy Japanese men, NCT02648438 in healthy male subjects, NCT03976869 in adolescents with asthma, and NCT04072562 in healthy subjects. All trials have been completed with a total enrollment of 117 participants.
AZD7594 is not known to have alternative names. It is a distinct investigational compound developed by AstraZeneca. No other names for this drug have been identified in clinical trial records or development information.