A Study to Assess the Safety of MEDI7836 in Healthy Adults. | NCT02388347

NCT02388347

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.	Drug: Placebo SC
MEDI7836 Dose 1	Experimental	Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.	Biological: MEDI7836 Dose 1
MEDI7836 Dose 2	Experimental	Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.	Biological: MEDI7836 Dose 2
MEDI7836 Dose 3	Experimental	Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.	Biological: MEDI7836 Dose 3
MEDI7836 Dose 4	Experimental	Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.	Biological: MEDI7836 Dose 4

Name	Type	Description	Arm Group Labels	Other Names
Placebo SC	Drug	Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	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.	From Study Drug Administration to 281 Days Postdose
Number of Participants With Injection Site Reactions	Participants were evaluated for manifestations of injection site reactions.	From Study Drug Administration to 281 Days Postdose
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events	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.	From Study Drug Administration to 281 Days Postdose
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events	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.

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836	Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).	Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Vital signs, ECG, and laboratory parameters within normal range at screening and Day -1
Negative alcohol and drug screen at screening and Day -1
Able and willing to comply with the requirements of the protocol
Females subjects must have been surgically sterilised or be postmenopausal
Nonsterilised males who are sexually active with a female partner of childbearing potential or a female partner who has been surgically sterilised by bilateral tubal ligation must use a condom with spermicide with their partner from screening until the end of the study follow-up period

Exclusion Criteria:

Concurrent enrolment in another clinical study where the subject is receiving an investigational product
Individuals who are legally institutionalised
Receipt of any marketed or investigational biologic agent within 4 months
Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half-lives of Day 1,
Known history of allergy or reaction to any component of the investigational product formulation
History of anaphylaxis following any biologic therapy
History of chronic alcohol or drug abuse within 12 months prior to screening,
Presence of a positive drug or alcohol screen at screening and Day -1.
Current smoker, or history of smoking within 6 months of screening
Pregnant or breastfeeding women
Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study
Any clinically relevant abnormal findings in physical examination, ECG, vital signs, haematology, clinical chemistry or urinalysis during screening or Day -1,
History of any known primary immunodeficiency disorder or use of immunosuppressive medication within 12 months of screening
History of a clinically significant infection requiring antibiotics or antiviral medication from 30 days prior to screening, up to and including Day 1
Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy
History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening
Positive tuberculosis (TB) test (Quantiferon-TB Gold) at screening or TB requiring treatment within the 12 months prior to the screening visit
Positive hepatitis B surface antigen, hepatitis B anti-core antibody, or hepatitis C virus antibody serology at screening.
Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enter the study.
A positive human immunodeficiency virus test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report
Evidence of active liver disease, including jaundice or aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)
Major surgery within 8 weeks prior to screening, or planed in-patient surgery or hospitalisation during the study period
Receipt of live attenuated vaccines 30 days prior to the date of screening Where participation in the study would result in donation of blood or blood products in excess of 500 mL within an 8-week period

Name	Affiliation	Role
Annelize Koch, MD	Parexel	Principal Investigator

ID	Title	Description
FG000	Placebo	Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
FG001	MEDI7836 Dose 1	Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
FG002	MEDI7836 Dose 2	Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
FG003	MEDI7836 Dose 3	Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
FG004	MEDI7836 Dose 4	Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
BG001	MEDI7836 Dose 1	Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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.

As Treated Population included all randomized participants and treated with MEDI7836 or placebo.

Posted

Number

Participant

From Study Drug Administration to 281 Days Postdose

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.