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AZD7624

Phase 1

LPS Challenge, Neutrophils | Small molecule | Other |AstraZeneca PLC|Last Updated: May 7, 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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01937338Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin ChallengePHASE1 COMPLETED 60 — — Oct 1, 2013Apr 1, 2014May 7, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Description of the pharmacodynamic Neutrophil lipopolysaccharide (LPS) response after a single dose AZD7624 in terms of % change in neutrophil differential from baseline
Sample taken at baseline visit (7-14 days before dose) and at 6h after dose day1 for each treatment. (up to 7 weeks)
Secondary Endpoints
Description of the efficacy in terms of effect of a single dose of inhaled AZD7624 on levels of TNF-α induced sputum after oral inhalation of LPS will be evaluated compared to placebo
Sample taken at baseline visit (7-14 days before dose) and at 6h after dose day1 for each treatment. (up to 7 weeks)
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry ,Creatinin kinase and myoglobin; haematology assessments, and forced expiratory volume in one second
From Screening to follow up (up to 9 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD7624EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD7624DRUGnebuliser solution; 20 mg/mL for inhalation
PlaceboDRUGnebuliser solution for inhalation
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, and ECG performed before the first administration of ...

Countries:United Kingdom
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