A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02114268
Collaborator
(none)
342
1
6
14
24.4
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.
Study Design
Study Type:
Interventional
Actual Enrollment
:
342 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Study Start Date
:
Apr 1, 2014
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEDI8897 300 milligram (mg) Intravenous (IV) Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
Drug: MEDI8897 Intravenous
Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
|
| Experimental: MEDI8897 1000 mg IV Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
Drug: MEDI8897 Intravenous
Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
|
| Experimental: MEDI8897 3000 mg IV Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
Drug: MEDI8897 Intravenous
Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
|
| Experimental: MEDI8897 100 mg Intramuscular (IM) Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
Drug: MEDI8897 Intramuscular
Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
|
| Experimental: MEDI8897 300 mg IM Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
Drug: MEDI8897 Intramuscular
Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
|
| Placebo Comparator: Placebo Participants received placebo on Day 1. |
Drug: Placebo
Participants received placebo on Day 1.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [From start of study drug administration up to Day 391 (Day 361 +/- 30 days)]
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Secondary Outcome Measures
- Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Maximum Observed Serum Concentration (Cmax) for MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Terminal Phase Elimination Half Life (t1/2) for MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Systemic Clearance (CL) for MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Volume of Distribution (Vz) for MEDI8897 [Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361]
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
- Number of Participants With Positive Anti-Drug Antibody (ADA) [Predose and Day 15, 31, 91, 181, 271 and 361]
Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:
-
Age 18 through 49 years and in good health by history, physical exam, and labs
-
Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening
-
Written informed consent prior to performing any protocol related procedures, including Screening evaluations
-
Ability to complete the Follow-up period of 360 days
Key Exclusion Criteria:
-
Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing
-
Any drug therapy within 7 days prior to Day 1 (except contraceptives)
-
Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
-
Previous receipt of a monoclonal antibody (mAb)
-
Pregnant or nursing mother
-
Concurrent enrollment in another interventional study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Overland Park | Kansas | United States |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Study Director: M. Pamela Griffin, MD, MedImmune LLC
- Principal Investigator: Martin Kankam, MD, PhD, MPH, Study Site
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02114268
Other Study ID Numbers:
- D5290C00001
First Posted:
Apr 15, 2014
Last Update Posted:
Nov 28, 2016
Last Verified:
Oct 1, 2016
Keywords provided by MedImmune LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study. |
| Arm/Group Title | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Period Title: Overall Study | ||||||
| STARTED | 34 | 6 | 6 | 6 | 6 | 78 |
| COMPLETED | 28 | 5 | 5 | 6 | 6 | 75 |
| NOT COMPLETED | 6 | 1 | 1 | 0 | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. | Total of all reporting groups |
| Overall Participants | 34 | 6 | 6 | 6 | 6 | 78 | 136 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
29.2
(8.6)
|
34.5
(8.6)
|
34.3
(5.6)
|
33.5
(6.7)
|
30.7
(7.8)
|
30.3
(7.9)
|
30.5
(8.0)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
19
55.9%
|
4
66.7%
|
2
33.3%
|
3
50%
|
6
100%
|
39
50%
|
73
53.7%
|
| Male |
15
44.1%
|
2
33.3%
|
4
66.7%
|
3
50%
|
0
0%
|
39
50%
|
63
46.3%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
|---|---|
| Description | An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug. |
| Time Frame | From start of study drug administration up to Day 391 (Day 361 +/- 30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The As-treated population included participants who receive any study investigational product. |
| Arm/Group Title | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 34 | 6 | 6 | 6 | 6 | 78 |
| TEAEs |
21
61.8%
|
3
50%
|
3
50%
|
5
83.3%
|
4
66.7%
|
48
61.5%
|
| TESAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
2.6%
|
| Title | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 |
|---|---|
| Description | The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 6 | 6 | 6 | 6 | 78 |
| Mean (Standard Deviation) [Day] |
0.078
(172)
|
0.059
(0)
|
0.209
(62.7)
|
5.46
(71.4)
|
9.42
(78.4)
|
| Title | Maximum Observed Serum Concentration (Cmax) for MEDI8897 |
|---|---|
| Description | The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 6 | 6 | 6 | 6 | 78 |
| Mean (Standard Deviation) [microgram per milliliter (mcg/ml)] |
96.98
(21.9)
|
333.80
(22.4)
|
1163.32
(23.8)
|
20.40
(29.4)
|
47.48
(26.2)
|
| Title | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 |
|---|---|
| Description | The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 5 | 5 | 5 | 5 | 75 |
| Mean (Standard Deviation) [Day*microgram per milliliter] |
6714.75
(21.7)
|
25320.68
(17)
|
63580.33
(10.4)
|
2249.11
(17.9)
|
5193.73
(32.1)
|
| Title | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 |
|---|---|
| Description | The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 5 | 5 | 5 | 5 | 75 |
| Mean (Standard Deviation) [Day] |
116.52
(19.6)
|
92.0
(12.6)
|
89.81
(18.2)
|
102.61
(11.3)
|
85.29
(30.8)
|
| Title | Systemic Clearance (CL) for MEDI8897 |
|---|---|
| Description | Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 5 | 5 | 5 | 5 | 75 |
| Mean (Standard Deviation) [ml per day] |
46.05
(17.3)
|
40.33
(15.4)
|
47.60
(10.6)
|
45.46
(15.4)
|
64.60
(37.7)
|
| Title | Volume of Distribution (Vz) for MEDI8897 |
|---|---|
| Description | The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time Frame | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. |
| Arm/Group Title | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 5 | 5 | 5 | 5 | 75 |
| Mean (Standard Deviation) [milliliter (ml)] |
7694.15
(24.8)
|
5426.89
(26.7)
|
6137.69
(18.5)
|
6808.78
(24.5)
|
7455.90
(34.0)
|
| Title | Number of Participants With Positive Anti-Drug Antibody (ADA) |
|---|---|
| Description | Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose. |
| Time Frame | Predose and Day 15, 31, 91, 181, 271 and 361 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The As-treated Population included participants who receive any study investigational product. |
| Arm/Group Title | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Measure Participants | 34 | 6 | 6 | 6 | 6 | 78 |
| Predose |
3
8.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
6.4%
|
| At Any Time Postdose |
5
14.7%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
13
16.7%
|
Adverse Events
| Time Frame | From Screening to Postdose Follow-up (up to 391 Days) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | ||||||
| Arm/Group Description | Participants received placebo on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. | ||||||
All Cause Mortality |
||||||||||||
| Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 2/78 (2.6%) | ||||||
| Infections and infestations | ||||||||||||
| Appendicitis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Gun shot wound | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/34 (61.8%) | 3/6 (50%) | 3/6 (50%) | 5/6 (83.3%) | 4/6 (66.7%) | 48/78 (61.5%) | ||||||
| Eye disorders | ||||||||||||
| Blepharospasm | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Lacrimation increased | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Vision blurred | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 3/78 (3.8%) | 3 |
| Abdominal pain upper | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Constipation | 1/34 (2.9%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Diarrhoea | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Dyspepsia | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 2 |
| Flatulence | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Food poisoning | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Nausea | 2/34 (5.9%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 3/78 (3.8%) | 3 |
| Salivary gland pain | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Vomiting | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 5/78 (6.4%) | 5 |
| General disorders | ||||||||||||
| Cyst | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Drug intolerance | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Fatigue | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Infusion site erythema | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Injection site pain | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/78 (1.3%) | 1 |
| Pyrexia | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Immune system disorders | ||||||||||||
| Seasonal allergy | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Acarodermatitis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Bacterial infection | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Bacterial vaginosis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/78 (2.6%) | 2 |
| Bronchitis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Candida infection | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Cellulitis | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Chlamydial infection | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Conjunctivitis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Conjunctivitis viral | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Gastroenteritis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Herpes simplex | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Injection site infection | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Pharyngitis | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/78 (2.6%) | 2 |
| Pharyngitis streptococcal | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Staphylococcal infection | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Tooth abscess | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Upper respiratory tract infection | 3/34 (8.8%) | 3 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 16/78 (20.5%) | 19 |
| Urinary tract infection | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 4/78 (5.1%) | 5 |
| Viral upper respiratory tract infection | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Arthropod bite | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Bone contusion | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Comminuted fracture | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Eye injury | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Foot fracture | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Laceration | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Muscle strain | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Post concussion syndrome | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Rib fracture | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Sunburn | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Tooth fracture | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Investigations | ||||||||||||
| Blood bilirubin increased | 0/34 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Blood creatine phosphokinase increased | 2/34 (5.9%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Metabolism and nutrition disorders | ||||||||||||
| Hyperglycaemia | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Type 2 diabetes mellitus | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 3/78 (3.8%) | 3 |
| Back pain | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Musculoskeletal pain | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 4/78 (5.1%) | 4 |
| Myalgia | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Neck pain | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Tendonitis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Nervous system disorders | ||||||||||||
| Dizziness | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Headache | 6/34 (17.6%) | 6 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 7/78 (9%) | 8 |
| Neuropathy peripheral | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Paraesthesia | 2/34 (5.9%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Presyncope | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/78 (0%) | 0 |
| Somnolence | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Syncope | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Psychiatric disorders | ||||||||||||
| Anxiety | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Depression | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Insomnia | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Post-traumatic stress disorder | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Reproductive system and breast disorders | ||||||||||||
| Menorrhagia | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Polycystic ovaries | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Cough | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 4/78 (5.1%) | 4 |
| Dyspnoea | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/78 (1.3%) | 1 |
| Dyspnoea exertional | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Epistaxis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Nasal congestion | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Rhinitis allergic | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/78 (0%) | 0 |
| Sinus congestion | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Tachypnoea | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Dermatitis | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Dermatitis allergic | 1/34 (2.9%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/78 (0%) | 0 |
| Dermatitis contact | 0/34 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 3/78 (3.8%) | 3 |
| Eczema | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hyperhidrosis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hyperkeratosis | 0/34 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/78 (1.3%) | 1 |
Limitations/Caveats
Physical examination parameters of participants were not evaluated.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | M. Pamela Griffin, MD, Senior Director |
|---|---|
| Organization | MedImmune, LLC |
| Phone | 301-398-0000 |
| information.center@astrazeneca.com |
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02114268
Other Study ID Numbers:
- D5290C00001
First Posted:
Apr 15, 2014
Last Update Posted:
Nov 28, 2016
Last Verified:
Oct 1, 2016