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ALXN1007

Phase 1

Healthy Subjects | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 31, 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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01883544Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female SubjectsPHASE1 COMPLETED 16Jun 1, 2013Jan 1, 2014Mar 31, 20141 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of multiple, IV doses of ALXN1007 in healthy male and female subjects as assessed by physical exam, vital signs, electrocardiogram (ECG), immunogenicity, laboratory analysis, and assessment of adverse events (AEs
90 days follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALXN1007EXPERIMENTALInfusion of ALXN1007
placeboPLACEBO_COMPARATORInfusion placebo
Interventions
NameTypeDescription
ALXN1007DRUG -
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Eligibility Criteria
Age Range25 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy male or female (not of childbearing potential) subjects ≥25 and ≤55 years old. 2\. QTcF ≤450 msec and ≤470 for females. 3. Willing and able to give written informed consent and comply with the study visit schedule. 4\. Male subject and his female spouse/partner who is ...

Countries:United States
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