Conditions: Asthma Chronic Obstructive Pulmonary Disease COPD
Keywords: Safety Pharmacokinetics Pharmacodynamics Glucocorticoid receptor modulator Healthy male subjects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: yes

Brief summary:
This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)

Detailed description:
This is a phase I, randomized, single-blind, placebo controlled, sequential-group design study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 after single and multiple ascending doses given once daily by inhalation in healthy male Japanese subjects, compared with placebo

Arms:
arm 1: AZD7594 inhalation powder (200 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 2: AZD7594 inhalation powder (400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 3: 1600 μg AZD7594 inhalation powder (4 x 400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI) arm 4: 400 μg AZD7594 pressurized inhalation suspension (2 x 200 μg inhalations) or placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

Interventions: intervention 1: AZD7594 inhalation powder (200 μg) intervention 2: AZD7594 inhalation powder (400 μg) intervention 3: AZD7594 pressurized inhalation suspension (200 μg) intervention 4: AZD7594 placebo inhalation powder intervention 5: AZD7594 placebo pressurized inhalation suspension
Intervention descriptions: intervention 1: 200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI) intervention 2: 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 intervention 3: 400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI) intervention 4: AZD7594 placebo inhalation powder via multi-dose DPI intervention 5: AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

Protocol document: