Recent Updates
Recently added Catalysts

AZD7594 for infusion

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Jun 15, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

AZD7594 for infusion clinical trials

AZD7594 for infusion · 1 trial · 2 indications

Phase 1 1
NCT02648438A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male SubjectsAsthma
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)
0-96 hours

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

Secondary Endpoints

PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)
0-96 hours
Observed Maximum Plasma Concentration (Cmax)
0-96 hours
Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)
0-96 hours
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment sequence 1EXPERIMENTALTreatment 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 2EXPERIMENTALTreatment 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)

Interventions

NameTypeDescription
AZD7594 Solution for infusion (150 μg intravenous formulation)DRUGSolution for infusion 0.01 mg/ml; AZD7594 150 μg IV
AZD7594 Oral suspension (1200 μg oral formulation)DRUG0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral
AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)DRUGInhalation 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)DRUGInhalation 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 pMDIDRUGInhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venipuncture. 3. Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and we...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about AZD7594 for infusion

What is AZD7594 for infusion?

AZD7594 for infusion is an intravenous formulation of AZD7594, a small molecule being developed by AstraZeneca for asthma. The specific formulation is described as AZD7594 Solution for infusion, a 150 microgram intravenous version. It is an investigational agent in Phase 1 clinical development and has not been approved for any use.

What is AZD7594 for infusion used for?

AZD7594 for infusion is being studied for asthma, which falls within the respiratory therapeutic area. The clinical trial involving this formulation also listed chronic obstructive pulmonary disease, or COPD, among the conditions studied. It remains investigational and is not an approved treatment for asthma or any other condition.

Who makes AZD7594 for infusion?

AZD7594 for infusion is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor behind the clinical program evaluating this intravenous formulation of the small molecule AZD7594 for respiratory indications including asthma.

What phase is AZD7594 for infusion in?

AZD7594 for infusion is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational, meaning it has not received regulatory approval and remains in early-stage clinical testing for asthma.

What clinical trials is AZD7594 for infusion in?

AZD7594 for infusion was evaluated in the Phase 1 trial NCT02648438, titled a study to assess the bioavailability and compare the pharmacokinetics of AZD7594 inhaled via monodose inhaler and multiple-dose dry powder inhalers or pressurized metered-dose inhaler in healthy male subjects. The trial enrolled 30 participants in the United States and is completed.

Is AZD7594 for infusion the same as AZD7594 Solution for infusion?

Yes, AZD7594 for infusion is also known as AZD7594 Solution for infusion, the 150 microgram intravenous formulation. Both names refer to the same intravenous presentation of AZD7594, the small molecule AstraZeneca is developing for asthma. The intravenous formulation is distinct from the inhaled formulations studied in the same Phase 1 program.