Trial Outcomes & Findings for Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults (NCT NCT02255760)
NCT ID: NCT02255760
Last Updated: 2018-08-13
Results Overview
An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is 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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Day 1 to Day 29
Results posted on
2018-08-13
Participant Flow
A total of 131 participants were screened, of which 75 did not meet eligibility criteria and were considered as screen failures; and the remaining 56 participants were randomized into the study.
Participant milestones
| Measure |
Placebo
Participants received a single dose of placebo by intravenous (IV) infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
3
|
15
|
15
|
9
|
|
Overall Study
COMPLETED
|
14
|
2
|
15
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single dose of placebo by intravenous (IV) infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
40.9 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
40.3 Years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
39.8 Years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
40.3 Years
STANDARD_DEVIATION 11.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is 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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
4 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 61Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
TEAESIs
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 29Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dosePopulation: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=8 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
|
694 micrograms*day/milliliters
Standard Deviation 133
|
2149 micrograms*day/milliliters
Standard Deviation 625
|
4246 micrograms*day/milliliters
Standard Deviation 1117
|
6540 micrograms*day/milliliters
Standard Deviation 1817
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dosePopulation: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=8 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
|
100 micrograms/milliliter
Standard Deviation 6
|
207 micrograms/milliliter
Standard Deviation 36
|
468 micrograms/milliliter
Standard Deviation 134
|
838 micrograms/milliliter
Standard Deviation 181
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dosePopulation: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=8 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (t1/2)
|
7.2 Days
Standard Deviation 0.9
|
9.0 Days
Standard Deviation 2.1
|
9.4 Days
Standard Deviation 1.6
|
8.4 Days
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dosePopulation: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=8 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
3412 milliliters
Standard Deviation 107
|
4022 milliliters
Standard Deviation 577
|
4326 milliliters
Standard Deviation 1246
|
4909 milliliters
Standard Deviation 1022
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dosePopulation: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=8 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
MEDI3902 Serum Clearance (CL) of MEDI3902
|
371 milliliters/day
Standard Deviation 79
|
371 milliliters/day
Standard Deviation 101
|
373 milliliters/day
Standard Deviation 83
|
489 milliliters/day
Standard Deviation 128
|
—
|
SECONDARY outcome
Timeframe: Days 1 (pre-dose), 15, 29, and 61Population: Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 Participants
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Pre-dose (Baseline)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
Day 61
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI3902 - Dose 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI3902 - Dose 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI3902 - Dose 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MEDI3902 - Dose 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours.
|
MEDI3902 - Dose 1
n=3 participants at risk
Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
|
MEDI3902 - Dose 2
n=15 participants at risk
Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
|
MEDI3902 - Dose 3
n=15 participants at risk
Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
|
MEDI3902 - Dose 4
n=9 participants at risk
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
11.1%
1/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
22.2%
2/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
26.7%
4/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
40.0%
6/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
55.6%
5/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
33.3%
1/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
13.3%
2/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
22.2%
2/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
22.2%
2/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Eye disorders
Chalazion
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
33.3%
1/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
11.1%
1/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
7.1%
1/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
7.1%
1/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
11.1%
1/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
11.1%
1/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/14 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/3 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
6.7%
1/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/15 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
0.00%
0/9 • Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
|
Additional Information
Hasan S. Jafri, MD, Senior Director, Clinical Development
MedImmune LLC
Phone: 301-398-0000
Email: [email protected]
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