Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02151110
Collaborator
(none)
59
1
8
23.4
2.5
Study Details
Study Description
Brief Summary
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
Actual Study Start Date
:
May 27, 2014
Actual Primary Completion Date
:
May 9, 2016
Actual Study Completion Date
:
May 9, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
Other: Placebo
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
|
| Experimental: MEDI4920 3 mg Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
Biological: MEDI4920 3 mg
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
|
| Experimental: MEDI4920 10 mg Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
Biological: MEDI4920 10 mg
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
|
| Experimental: MEDI4920 30 mg Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
Biological: MEDI4920 30 mg
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
|
| Experimental: MEDI4920 100 mg Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
Biological: MEDI4920 100 mg
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
|
| Experimental: MEDI4920 300 mg Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
Biological: MEDI4920 300 mg
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
|
| Experimental: MEDI4920 1000 mg Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
Biological: MEDI4920 1000 mg
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
|
| Experimental: MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
Biological: MEDI4920 3000 mg
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit]
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.
Secondary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Terminal Elimination Half Life (t1/2) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Systemic Clearance (CL) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Volume of Distribution at Steady-state (Vss) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920 [Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first]
The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
- Percentage of Participants Positive for Anti-drug Antibodies (ADA) [Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first]
Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented.
- T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration [Day 43]
The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy as determined by a responsible study physician based on medical evaluation
-
Body weight 40 to 100 kg
-
Body mass index 19.0 to 30.0 kg/m2
Exclusion Criteria:
-
History of allergy or sensitivity to Shellfish or protein based antigens
-
previous immunization with KLH
-
previous splenectomy
-
History of diagnosed or suspected thromboembolic event or coagulation disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Leeds | United Kingdom | LS2 9LH |
Sponsors and Collaborators
- MedImmune LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02151110
Other Study ID Numbers:
- D5100C00001
First Posted:
May 30, 2014
Last Update Posted:
Feb 15, 2019
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MedImmune LLC
Study Results
Participant Flow
| Recruitment Details | Healthy adult male and female participants were recruited in a blinded manner. The study was conducted at one site in the United Kingdom. |
|---|---|
| Pre-assignment Detail | A total of 259 participants were screened of which 200 participants were considered screen failures and the remaining 59 participants were randomized. Out of which, 56 participants were treated |
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Period Title: Overall Study | ||||||||
| STARTED | 12 | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| COMPLETED | 12 | 2 | 2 | 8 | 8 | 8 | 8 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg | TOTAL |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. | Total of all reporting groups |
| Overall Participants | 12 | 2 | 2 | 8 | 8 | 8 | 8 | 8 | 56 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [Years] |
33.3
(8.9)
|
27.5
(4.9)
|
26.0
(1.4)
|
27.8
(12.3)
|
28.1
(10.1)
|
38.4
(9.3)
|
33.3
(9.2)
|
32.0
(9.8)
|
31.8
(9.8)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
12
100%
|
2
100%
|
2
100%
|
8
100%
|
8
100%
|
8
100%
|
8
100%
|
8
100%
|
56
100%
|
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 any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0. |
| Time Frame | The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population: All participants who received any study drug were included in this population |
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 12 | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| TEAEs |
10
83.3%
|
1
50%
|
1
50%
|
5
62.5%
|
8
100%
|
3
37.5%
|
5
62.5%
|
7
87.5%
|
| TESAEs |
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Maximum Observed Plasma Concentration (Cmax) of MEDI4920 |
|---|---|
| Description | The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [microgram per milliliter (µg/mL)] |
1.00
(NA)
|
4.46
(NA)
|
7.97
(0.873)
|
23.6
(2.76)
|
85.6
(17.6)
|
289
(58.1)
|
960
(126)
|
| Title | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920 |
|---|---|
| Description | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [microgram*day per milliliter (µg*d/mL)] |
3.64
(NA)
|
19.3
(NA)
|
53.4
(10.9)
|
151
(20.2)
|
581
(38.3)
|
2090
(394)
|
6640
(553)
|
| Title | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920 |
|---|---|
| Description | The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [microgram*day per milliliter (µg*d/mL)] |
4.60
(NA)
|
20.5
(NA)
|
54.8
(11.0)
|
152
(20.2)
|
583
(37.8)
|
2090
(394)
|
6640
(547)
|
| Title | Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920 |
|---|---|
| Description | The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [µg*d/mL/mg] |
1.53
(NA)
|
2.05
(NA)
|
1.83
(0.366)
|
1.52
(0.202)
|
1.94
(0.126)
|
2.09
(0.394)
|
2.21
(0.182)
|
| Title | Terminal Elimination Half Life (t1/2) of MEDI4920 |
|---|---|
| Description | The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [Day(s)] |
4.41
(NA)
|
5.35
(NA)
|
5.31
(2.30)
|
5.49
(1.59)
|
8.86
(1.60)
|
9.68
(1.25)
|
10.1
(1.87)
|
| Title | Systemic Clearance (CL) of MEDI4920 |
|---|---|
| Description | The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [milliliter per day (mL/day)] |
661
(NA)
|
487
(NA)
|
564
(96.8)
|
668
(90.4)
|
517
(33.5)
|
494
(102)
|
454
(37.9)
|
| Title | Volume of Distribution at Steady-state (Vss) of MEDI4920 |
|---|---|
| Description | The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [milliliter (mL)] |
3980
(NA)
|
3290
(NA)
|
4280
(684)
|
5560
(806)
|
5180
(811)
|
5450
(1150)
|
4900
(715)
|
| Title | Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920 |
|---|---|
| Description | The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3. |
| Time Frame | Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population |
| Arm/Group Title | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [milliliter (mL)] |
4130
(NA)
|
3760
(NA)
|
4080
(1090)
|
5230
(1360)
|
6590
(1160)
|
6880
(1520)
|
6600
(1190)
|
| Title | Percentage of Participants Positive for Anti-drug Antibodies (ADA) |
|---|---|
| Description | Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented. |
| Time Frame | Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population. |
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 12 | 2 | 2 | 8 | 8 | 8 | 8 | 8 |
| Baseline ADA positive |
16.7
139.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Post-baseline ADA positive |
8.3
69.2%
|
50
2500%
|
100
5000%
|
100
1250%
|
87.5
1093.8%
|
37.5
468.8%
|
37.5
468.8%
|
12.5
156.3%
|
| Title | T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration |
|---|---|
| Description | The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model. |
| Time Frame | Day 43 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated Population. |
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Measure Participants | 11 | 2 | 2 | 8 | 7 | 8 | 8 | 8 |
| Geometric Mean (95% Confidence Interval) [nanogram per milliliter (ng/mL)] |
NA
|
0.99
|
0.96
|
0.88
|
0.68
|
0.42
|
0.22
|
0.14
|
Adverse Events
| Time Frame | Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit). | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg | ||||||||
| Arm/Group Description | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. | ||||||||
All Cause Mortality |
||||||||||||||||
| Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | 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 | 0/12 (0%) | 0/2 (0%) | 0/2 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | 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 | 1/12 (8.3%) | 0/2 (0%) | 0/2 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Tibia fracture | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Placebo | MEDI4920 3 mg | MEDI4920 10 mg | MEDI4920 30 mg | MEDI4920 100 mg | MEDI4920 300 mg | MEDI4920 1000 mg | MEDI4920 3000 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | 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 | 10/12 (83.3%) | 1/2 (50%) | 1/2 (50%) | 5/8 (62.5%) | 8/8 (100%) | 3/8 (37.5%) | 5/8 (62.5%) | 7/8 (87.5%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Ear discomfort | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Eye disorders | ||||||||||||||||
| Blepharitis | 0/12 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Eye inflammation | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Ocular hyperaemia | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Vision blurred | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 |
| Diarrhoea | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 1/8 (12.5%) | 1 |
| Nausea | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Toothache | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 |
| Vomiting | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| General disorders | ||||||||||||||||
| Fatigue | 1/12 (8.3%) | 2 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Feeling hot | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Immune system disorders | ||||||||||||||||
| Seasonal allergy | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Herpes zoster | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Hordeolum | 0/12 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Influenza | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 |
| Nasopharyngitis | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/8 (0%) | 0 | 5/8 (62.5%) | 5 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 |
| Oral herpes | 1/12 (8.3%) | 2 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 |
| Rash pustular | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Arthropod bite | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Joint dislocation | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||
| Decreased appetite | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Back pain | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 |
| Musculoskeletal stiffness | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Neck pain | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Dizziness | 2/12 (16.7%) | 2 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Headache | 4/12 (33.3%) | 4 | 0/2 (0%) | 0 | 1/2 (50%) | 2 | 2/8 (25%) | 3 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 2 | 3/8 (37.5%) | 3 |
| Memory impairment | 0/12 (0%) | 0 | 1/2 (50%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Migraine | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 |
| Paraesthesia | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Product Issues | ||||||||||||||||
| Device failure | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 |
| Nasal congestion | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 |
| Oropharyngeal pain | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 1/2 (50%) | 1 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 |
| Rhinorrhoea | 1/12 (8.3%) | 2 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Eczema | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Hyperhidrosis | 0/12 (0%) | 0 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
| Night sweats | 1/12 (8.3%) | 1 | 0/2 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 |
Limitations/Caveats
[Not Specified]
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 | David Howe, MBChB, MD, MRCOG |
|---|---|
| Organization | MedImmune LLC |
| Phone | +44 (0) 1223 895980 |
| information.center@astrazenea.com |
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02151110
Other Study ID Numbers:
- D5100C00001
First Posted:
May 30, 2014
Last Update Posted:
Feb 15, 2019
Last Verified:
Sep 1, 2018