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MEDI8111

Phase 1

Healthy Subjects | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 4, 2016

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment157
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01958645To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.PHASE1 COMPLETED 157 — — Nov 1, 2013Oct 1, 2014Feb 4, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
From screening and up to the lab follow-up visit (Day 29)
Secondary Endpoints
Change From Baseline Endogenous Thrombin Potential (ETP)
Predose and Days 1-5
Change From Baseline Factor II Concentrations by ECL Assay
Predose and 1-8 hours
Change From Baseline Factor II Concentrations by Clot Assay
Predose and 1-8 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTALMEDI8111
BPLACEBO_COMPARATORPlacebo for MEDI8111
Interventions
NameTypeDescription
MEDI8111DRUGMEDI8111 lyophilisate for solution for infusion
PlaceboOTHERPlacebo for MEDI8111 saline solution for infusion
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at lea...

Countries:United Kingdom
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