Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7594 · 3 trials · 2 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
| 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) |
| 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) |
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...
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AZD7594 is an investigational inhaled small molecule being studied for the treatment of asthma. It has been evaluated in Phase 1 clinical trials in adolescents and adults with asthma, as well as in healthy volunteers. It is not approved for any indication and remains in clinical development.
AZD7594 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical program evaluating the drug in asthma and related respiratory conditions.
AZD7594 is in Phase 1 clinical development. All three of its reported trials are Phase 1 studies, and all three have been completed. The drug is investigational and has not been approved by the FDA or any other regulatory authority for asthma or any other indication.
AZD7594 has been studied in three completed Phase 1 trials: NCT04072562, which compared nebulized and dry powder inhaler delivery in healthy subjects in Germany; NCT03976869, a two-week pharmacokinetics, pharmacodynamics and safety study in adolescents with asthma in the United States; and NCT02645253, a safety, tolerability and pharmacokinetics study in healthy Japanese men.
Yes. AZD7594 oral suspension (1200 microgram oral formulation) and AZD7594 inhalation powder (200 microgram) are alternative names and formulations of the same investigational compound, AZD7594. The clinical program has evaluated inhaled delivery, including nebulizer and dry powder inhaler administration.
Across the three completed Phase 1 trials of AZD7594, a total of 87 participants have been enrolled. The studies were randomized and actively controlled, and they included healthy volunteers as well as adolescents and adults with asthma.