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MEDI-557

Phase 1

Healthy | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Nov 23, 2011

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00578682A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557PHASE1 COMPLETED 31 — — Dec 1, 2007Nov 1, 2010Nov 23, 20111 United States
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Study Endpoints
Primary Endpoints
The occurrence of AEs from the period immediately following study drug administration
through 28 days after dosing
The occurrence of laboratory AEs from the period immediately following study drug administration
through 90 days after dosing
The occurrence of SAEs from the period immediately following study drug administration
through 240 days after dosing
Secondary Endpoints
The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis.
Day 240
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSingle IV dose of 0.3 mg/kg MEDI-557
2EXPERIMENTALSingle IV dose of 3 mg/kg MEDI-557
3EXPERIMENTALSingle IV dose of 15 mg/kg MEDI-557
4EXPERIMENTALSingle IV dose of 30 mg/kg MEDI-557
Interventions
NameTypeDescription
MEDI-557BIOLOGICALSingle IV dose of 3 mg/kg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 18 through 45 years at the time of study entry; * Weight ≤ 90 kg; * Healthy by medical history and physical examination; * Normotensive (systolic blood pressure \[BP\] \< 150 mmHg and diastolic BP \<90 mmHg); * Normal electrocardiogram (ECG) at screening (must occur within...

Countries:United States
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