Approval Probability
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Adjusted LOA
ML Risk
800 μg AZD7594 once daily · 1 trial · 3 indications
Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \[IMP\] on Day 14) with placebo
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Placebo once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 2 | EXPERIMENTAL | Placebo once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 3 | EXPERIMENTAL | Placebo once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 4 | EXPERIMENTAL | 58 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 6 | EXPERIMENTAL | 250 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 8 | EXPERIMENTAL | 800 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3 |
| Sequence 5 | EXPERIMENTAL | 58 µg AZD7594 once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3 |
| Sequence 7 | EXPERIMENTAL | 250 µg AZD7594 once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3 |
| Sequence 9 | EXPERIMENTAL | 800 µg AZD7594 once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3 |
| Name | Type | Description |
|---|---|---|
| 800 μg AZD7594 once daily | DRUG | Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule |
| 250 µg AZD7594 once daily | DRUG | Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule |
| 58 µg AZD7594 once daily | DRUG | Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule |
| Placebo once daily | DRUG | Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule |
| Salbutamol | DRUG | Inhalation as needed |
Inclusion Criteria: * Body mass index of 18 to 35 kg/m2 * Men and women 18 to 75 years of age, inclusive * Patients need to be non-smokers or ex-smokers (quit ≥ 6 months before the Visit 1) with total smoking history of \< 10 pack years * Documented clinical diagnosis of asthma for ≥ 6 months befor...
AZD7594 is an investigational small molecule being developed for the treatment of asthma. It is administered once daily by inhalation. The drug is currently in Phase 2 clinical development, having completed a study in patients with mild to moderate asthma.
AZD7594 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with asthma.
AZD7594 is in Phase 2 clinical development. A Phase 2 trial has been completed, which assessed the efficacy and safety of three dose levels of the drug given once daily by inhalation in patients with mild to moderate asthma. The drug is not yet approved and remains investigational.
AZD7594 has one completed Phase 2 clinical trial registered as NCT02479412. This study evaluated three dose levels of AZD7594 administered once daily by inhalation over 14 days in patients with mild to moderate asthma. The trial enrolled 54 participants and was conducted in Bulgaria and Germany.
Yes, 800 μg AZD7594 once daily refers to a specific dose of AZD7594. The drug is administered by inhalation, and the 800 μg dose is one of the dose levels being studied in clinical trials for the treatment of asthma.