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MEDI5884 Dose 1

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Aug 22, 2018

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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03001297Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884PHASE1 COMPLETED 64 — — Jan 17, 2017Aug 10, 2018Aug 22, 20181 United States
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Study Endpoints
Primary Endpoints
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

HDL-Cholesterol over time
Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Secondary Endpoints
Lipoprotein particle size
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Lipoprotein particle number
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Levels of total cholesterol
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI5884 Dose 1EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.
PlaceboPLACEBO_COMPARATORPlacebo will be administered subcutaneously (SC).
MEDI5884 Dose 2EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.
MEDI5884 Dose 3EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.
MEDI5884 Dose 4EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.
Interventions
NameTypeDescription
PlaceboBIOLOGICALParticipants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
MEDI5884 Dose 1BIOLOGICALParticipants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
MEDI5884 Dose 2BIOLOGICALParticipants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
MEDI5884 Dose 3BIOLOGICALParticipants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
MEDI5884 Dose 4BIOLOGICALParticipants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers aged 18-55 years * Must provide written informed consent * Ability and willingness to adhere to the protocol * BMI 18-30kg/m2 * Females not of childbearing potential * Males must practice 2 effective contraceptive measures if sexually active * Japanese desce...

Countries:United States
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