AZD3199 - Healthy Volunteers | Phase 1 | AstraZeneca PLC | BiopharmaWatch

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AZD3199

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 10, 2014

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker

Total Trials1

Total Enrollment27

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT00713271	Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men	PHASE1	COMPLETED	27	—	—	Aug 1, 2008	Nov 1, 2008	Apr 10, 2014	1	Sweden

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Study Endpoints

Primary Endpoints

Incidence and nature of Adverse Events

Before, during and after dosing

Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab

Before, during and after dosing

Secondary Endpoints

Pharmacokinetics

Before, during and after dosing

Potassium and lactate concentrations

Before, during and after dosing

Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1

Before, during and after dosing

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
1	EXPERIMENTAL	Low dose
2	EXPERIMENTAL	intermediate dose
3	EXPERIMENTAL	high dose
4	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
AZD3199	DRUG	Low dose Dry powder for inhalation, o.d., 1+12 days
Placebo	DRUG	-

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Eligibility Criteria

Age Range18 Years — 45 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * BMI 19-30, weight 60-100 kg * Non/ex-smokers, Non/ex-nicotine users Exclusion Criteria: * Any clinically significant disease or disorder * Any clinically relevant abnormal findings at screening examinations * Use of any prescribed or non-prescribed medication

Countries:Sweden

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