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AZD9819

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 9, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

AZD9819 · 1 trial · 3 indications

Phase 1 1
NCT01166698Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy SubjectsHealthy Volunteers
COMPLETED100 Analytics
PHASE1COMPLETED
Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
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Study Endpoints

Primary Endpoints

Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
Frequent safety measurements during the study from screening period to follow-up

Secondary Endpoints

Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma
Multiple PK blood samples from pre-dose until 96 hours post last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AZD9819EXPERIMENTALInhaled suspension
PlaceboPLACEBO_COMPARATORInhaled suspension

Interventions

NameTypeDescription
AZD9819DRUGInhaled single doses of suspension via SPIRA nebuliser
PlaceboDRUGInhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. * Have a body mass index (BMI) betw...

Countries:United Kingdom
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Frequently asked questions about AZD9819

What is AZD9819 used for?

AZD9819 is an investigational small molecule being studied in healthy volunteers to assess its safety and tolerability. It is administered as an inhaled dose. The drug is in Phase 1 clinical development and is not approved for any condition.

Who makes AZD9819?

AZD9819 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 safety and tolerability in healthy subjects.

What phase is AZD9819 in?

AZD9819 is in Phase 1 clinical development. A Phase 1 trial has been completed, which involved 100 healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is AZD9819 in?

AZD9819 has one completed Phase 1 trial, identified as NCT01166698. This was a single-center, double-blind, placebo-controlled study that evaluated single and multiple ascending inhaled doses of AZD9819 in healthy subjects in the United Kingdom.

Is AZD9819 FDA approved?

AZD9819 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety and tolerability in healthy volunteers, and the drug has not been authorized for any medical use.