Trial Outcomes & Findings for Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects (NCT NCT02669667)
NCT ID: NCT02669667
Last Updated: 2019-06-04
Results Overview
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
From the start of study drug administration upto Day 240
Results posted on
2019-06-04
Participant Flow
The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom.
A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo" in 7 treatment groups.
Participant milestones
| Measure |
Placebo
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
4
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
4
|
4
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
32.0 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
28.0 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
32.0 Years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
35.0 Years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
31.2 Years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
36.0 Years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
33.0 Years
STANDARD_DEVIATION 8.7 • n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
44 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
42 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
28 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
8 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
TEAEs observed in participants with clinically significant ECG abnormalities were reported.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
Adverse events observed in participants with clinically significant physical abnormalities were assessed.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Liver function test increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Transaminases increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration upto Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site haemorrhage
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Infusion site bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Infusion site erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Infusion site pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site bruising
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site erythema
|
2 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site induration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site pruritus
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Injection Site Reactions
Injection site warmth
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240Population: Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.
The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314
|
3.01 µg*d/mL
Standard Deviation NA
Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \<=2 parameter values.
|
68.8 µg*d/mL
Standard Deviation 47.3
|
179 µg*d/mL
Standard Deviation 105
|
264 µg*d/mL
Standard Deviation 159
|
668 µg*d/mL
Standard Deviation 132
|
1440 µg*d/mL
Standard Deviation 126
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240Population: The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.
The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)
|
2.94 μg*d/mL
Standard Deviation NA
Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \<=2 parameter values.
|
68.6 μg*d/mL
Standard Deviation 47.3
|
178 μg*d/mL
Standard Deviation 105
|
264 μg*d/mL
Standard Deviation 159
|
667 μg*d/mL
Standard Deviation 132
|
1439 μg*d/mL
Standard Deviation 126
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240Population: PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.
The maximum observed serum drug concentration of MEDI9314.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314
|
0.425 µg/mL
Standard Deviation 0.367
|
5.44 µg/mL
Standard Deviation 2.77
|
10.4 µg/mL
Standard Deviation 5.63
|
14.1 µg/mL
Standard Deviation 8.87
|
79.0 µg/mL
Standard Deviation 14.8
|
108 µg/mL
Standard Deviation 9.99
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240Population: PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.
The time to maximum observed serum drug concentration of MEDI9314.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314
|
4.00 Day
Interval 3.99 to 4.0
|
8.07 Day
Interval 2.99 to 9.03
|
5.52 Day
Interval 3.0 to 9.13
|
5.51 Day
Interval 3.99 to 9.08
|
0.04 Day
Interval 0.04 to 0.04
|
0.04 Day
Interval 0.04 to 0.04
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240Population: The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.
Terminal phase elimination half-life of MEDI9314
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (t1/2) of MEDI9314
|
1.74 Day
Standard Deviation NA
Only 2 out of 4 participants had sufficient elimination data for calculating those PK parameter in Cohort 1. Standard deviation of the mean was not provided when having \<=2 parameter values.
|
3.55 Day
Standard Deviation 0.685
|
4.72 Day
Standard Deviation 0.998
|
5.03 Day
Standard Deviation 1.13
|
7.31 Day
Standard Deviation 1.29
|
8.95 Day
Standard Deviation 1.14
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 [predose]) and Day 240Population: PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure.
Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=6 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Serum Concentrations of MEDI9314
Day 240
|
23.432 μg/mL
Standard Deviation 20.738
|
9.770 μg/mL
Standard Deviation 0.000
|
9.770 μg/mL
Standard Deviation 0.000
|
13.167 μg/mL
Standard Deviation 8.320
|
9.770 μg/mL
Standard Deviation 0.000
|
14.573 μg/mL
Standard Deviation 11.766
|
—
|
|
Serum Concentrations of MEDI9314
Baseline
|
21.495 μg/mL
Standard Deviation 14.790
|
9.770 μg/mL
Standard Deviation 0.000
|
22.577 μg/mL
Standard Deviation 31.370
|
9.770 μg/mL
Standard Deviation 0.000
|
9.770 μg/mL
Standard Deviation 0.000
|
9.770 μg/mL
Standard Deviation 0.000
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 [predose]) and Day 240Population: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 Participants
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 Participants
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 Participants
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 Participants
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 Participants
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 Participants
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
Baseline ADA positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
Day 240- ADA positive
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1.
|
Cohort 1
n=4 participants at risk
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
|
Cohort 2
n=4 participants at risk
Participants received a single SC injection of MEDI9314 150 mg on Day 1.
|
Cohort 3
n=6 participants at risk
Participants received a single SC injection of MEDI9314 300 mg on Day 1.
|
Cohort 4
n=6 participants at risk
Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1
|
Cohort 5
n=6 participants at risk
Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose.
|
Cohort 6
n=6 participants at risk
Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Infusion site bruising
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Infusion site erythema
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Infusion site pruritus
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site bruising
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site erythema
|
16.7%
2/12 • Number of events 2 • From the start of study drug administration upto Day 240
|
100.0%
4/4 • Number of events 4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
83.3%
5/6 • Number of events 5 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site haemorrhage
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site induration
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
66.7%
4/6 • Number of events 4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site pain
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Injection site warmth
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
3/12 • Number of events 3 • From the start of study drug administration upto Day 240
|
50.0%
2/4 • Number of events 2 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
33.3%
2/6 • Number of events 2 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
50.0%
3/6 • Number of events 4 • From the start of study drug administration upto Day 240
|
50.0%
3/6 • Number of events 5 • From the start of study drug administration upto Day 240
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Investigations
Liver function test increased
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Investigations
Transaminases increased
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 2 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
16.7%
1/6 • Number of events 1 • From the start of study drug administration upto Day 240
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From the start of study drug administration upto Day 240
|
25.0%
1/4 • Number of events 1 • From the start of study drug administration upto Day 240
|
0.00%
0/4 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
0.00%
0/6 • From the start of study drug administration upto Day 240
|
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 on-going 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