Recent Updates
Recently added Catalysts

AZD4818

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 1, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00687232Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male VolunteersPHASE1 COMPLETED 30Jan 1, 2008May 1, 2008Dec 1, 20101 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
During the study
Lab assessment
During the study
Secondary Endpoints
Pharmacokinetics
During the study
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD4818
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD4818DRUGDry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent * Body Mass Index (BMI) between 18.0-27.0 kg/m2 * No clinically relevant abnormal findings Exclusion Criteria: * Acute illness which requires medical intervention * Definite or suspected personal history of adverse drug reactions or drug hyperse...

Countries:Japan
Unlock Eligibility Criteria