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AZD9819

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Nov 9, 2011

AZD9819 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2010

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

AZD9819 clinical trials

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?

AZD9819 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial involving healthy volunteers, evaluating single and multiple ascending inhaled doses. The specific therapeutic indication for AZD9819 has not been disclosed.

Who is developing AZD9819?

AZD9819 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this investigational small molecule.

What phase is AZD9819 in?

AZD9819 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is AZD9819 in?

AZD9819 has been evaluated in one completed Phase 1 trial, NCT01166698, titled "Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects." The trial enrolled 100 healthy volunteers in the United Kingdom and assessed safety and tolerability.

How was the AZD9819 Phase 1 trial designed?

The Phase 1 trial NCT01166698 was a single-center, double-blind, placebo-controlled study of single and multiple ascending inhaled doses of AZD9819 in healthy subjects. It enrolled 100 participants aged 18 years and older of all sexes in the United Kingdom.