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MEDI7836 Dose 1

Phase 1

Healthy Adults | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: May 16, 2017

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 Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02388347A Study to Assess the Safety of MEDI7836 in Healthy Adults.PHASE1 COMPLETED 79Mar 1, 2015Apr 1, 2016May 16, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
From Study Drug Administration to 281 Days Postdose

Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Injection Site Reactions
From Study Drug Administration to 281 Days Postdose

Participants were evaluated for manifestations of injection site reactions.

Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
From Study Drug Administration to 281 Days Postdose

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.

Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
From Study Drug Administration to 281 Days Postdose

Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.

Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
From Study Drug Administration to 281 Days Postdose

AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.

Secondary Endpoints
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836
Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836
Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
Maximum Observed Serum Concentration (Cmax) of MEDI7836
Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
MEDI7836 Dose 1EXPERIMENTALParticipants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
MEDI7836 Dose 2EXPERIMENTALParticipants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
MEDI7836 Dose 3EXPERIMENTALParticipants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
MEDI7836 Dose 4EXPERIMENTALParticipants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
Interventions
NameTypeDescription
Placebo SCDRUGParticipants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
MEDI7836 Dose 1BIOLOGICALParticipants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
MEDI7836 Dose 2BIOLOGICALParticipants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
MEDI7836 Dose 3BIOLOGICALParticipants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
MEDI7836 Dose 4BIOLOGICALParticipants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1 2. Negative alcohol and drug screen at screening and Day -1 3. Able and willing to comply with the requirements of the protocol 4. Females subjects must have been surgically sterilised or ...

Countries:United Kingdom
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