Trial Outcomes & Findings for A Study to Assess the Safety of MEDI7836 in Healthy Adults. (NCT NCT02388347)
NCT ID: NCT02388347
Last Updated: 2017-05-16
Results Overview
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.
COMPLETED
PHASE1
79 participants
From Study Drug Administration to 281 Days Postdose
2017-05-16
Participant Flow
A total of 79 participants were screened. Of these, 32 participants were randomized and treated in the study.
Participant milestones
| Measure |
Placebo
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Safety of MEDI7836 in Healthy Adults.
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.4 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
32.8 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
32.8 Years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
32.0 Years
STANDARD_DEVIATION 14.0 • n=21 Participants
|
34.6 Years
STANDARD_DEVIATION 10.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Study Drug Administration to 281 Days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
6 Participant
|
4 Participant
|
6 Participant
|
5 Participant
|
6 Participant
|
|
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From Study Drug Administration to 281 Days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.
Participants were evaluated for manifestations of injection site reactions.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions
|
4 Participant
|
2 Participant
|
3 Participant
|
0 Participant
|
5 Participant
|
PRIMARY outcome
Timeframe: From Study Drug Administration to 281 Days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Platelet count decreased
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Aspartate aminotransferase increased
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
1 Participant
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Transaminases increased
|
1 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From Study Drug Administration to 281 Days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
PRIMARY outcome
Timeframe: From Study Drug Administration to 281 Days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: Pharmacokinetic (PK) Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836
|
62.958 Day*microgram per milliliter
Standard Deviation 29.629
|
310.805 Day*microgram per milliliter
Standard Deviation 204.858
|
807.725 Day*microgram per milliliter
Standard Deviation 418.083
|
1101.742 Day*microgram per milliliter
Standard Deviation 817.295
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836
|
62.106 day*mcg/mL
Standard Deviation 29.237
|
308.965 day*mcg/mL
Standard Deviation 203.367
|
799.769 day*mcg/mL
Standard Deviation 406.585
|
1096.620 day*mcg/mL
Standard Deviation 807.266
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
The Cmax is the maximum observed serum concentration of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI7836
|
1.587 microgram per milliliter (mcg/mL)
Standard Deviation 0.436
|
10.435 microgram per milliliter (mcg/mL)
Standard Deviation 1.520
|
24.600 microgram per milliliter (mcg/mL)
Standard Deviation 5.313
|
41.933 microgram per milliliter (mcg/mL)
Standard Deviation 7.208
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Systemic Clearance (CL/F) of MEDI7836
|
616.206 milliliter per day (mL/day)
Standard Deviation 422.587
|
481.219 milliliter per day (mL/day)
Standard Deviation 282.488
|
463.827 milliliter per day (mL/day)
Standard Deviation 226.960
|
706.952 milliliter per day (mL/day)
Standard Deviation 283.588
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Phase Elimination Half Life (T1/2) of MEDI7836
|
26.988 day
Standard Deviation 14.902
|
28.091 day
Standard Deviation 14.121
|
36.944 day
Standard Deviation 9.329
|
37.013 day
Standard Deviation 5.185
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836
|
4.0 day
Interval 4.0 to 15.0
|
5.0 day
Interval 3.0 to 8.0
|
5.0 day
Interval 3.0 to 10.0
|
6.0 day
Interval 4.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 PostdosePopulation: PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.
The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836
|
18885.105 mL
Standard Deviation 7689.663
|
15032.685 mL
Standard Deviation 6066.111
|
22930.365 mL
Standard Deviation 8180.111
|
36686.872 mL
Standard Deviation 14142.345
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 to 281 days PostdosePopulation: As Treated Population included all randomized participants and treated with MEDI7836 or placebo. Here, "n" is number of participants analysed at given time point.
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 Participants
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836
Baseline (n=8,6,6,6,6)
|
25.0 Percentage of participant
|
33.3 Percentage of participant
|
66.7 Percentage of participant
|
50.0 Percentage of participant
|
50.0 Percentage of participant
|
|
Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836
Post-Baseline Day 281 (n=8,6,5,6,6)
|
12.5 Percentage of participant
|
66.7 Percentage of participant
|
20.0 Percentage of participant
|
50.0 Percentage of participant
|
50.0 Percentage of participant
|
Adverse Events
Placebo
MEDI7836 Dose 1
MEDI7836 Dose 2
MEDI7836 Dose 3
MEDI7836 Dose 4
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 1
n=6 participants at risk
Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 2
n=6 participants at risk
Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 3
n=6 participants at risk
Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
|
MEDI7836 Dose 4
n=6 participants at risk
Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
2/8 • Number of events 3 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
|
General disorders
Injection site reaction
|
50.0%
4/8 • Number of events 6 • From Study Drug Administration to 281 Days Postdose
|
33.3%
2/6 • Number of events 2 • From Study Drug Administration to 281 Days Postdose
|
50.0%
3/6 • Number of events 3 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
83.3%
5/6 • Number of events 11 • From Study Drug Administration to 281 Days Postdose
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
33.3%
2/6 • Number of events 3 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Number of events 2 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
33.3%
2/6 • Number of events 3 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
|
Investigations
Transaminases increased
|
12.5%
1/8 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 5 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
33.3%
2/6 • Number of events 2 • From Study Drug Administration to 281 Days Postdose
|
33.3%
2/6 • Number of events 2 • From Study Drug Administration to 281 Days Postdose
|
50.0%
3/6 • Number of events 3 • From Study Drug Administration to 281 Days Postdose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
0.00%
0/6 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
16.7%
1/6 • Number of events 1 • From Study Drug Administration to 281 Days Postdose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER