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Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
|
| MEDI4920 3 mg | Experimental | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
|
| MEDI4920 10 mg | Experimental | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
|
| MEDI4920 30 mg | Experimental | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
|
| MEDI4920 100 mg | Experimental | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
|
| MEDI4920 300 mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI4920 3 mg | Biological | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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. | The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of MEDI4920 | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leeds | LS2 9LH | United Kingdom |
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
Healthy adult male and female participants were recruited in a blinded manner. The study was conducted at one site in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
| FG001 | MEDI4920 3 mg | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
|
| MEDI4920 1000 mg | Experimental | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
|
| MEDI4920 3000 mg | Experimental | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
| MEDI4920 10 mg | Biological | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
|
| MEDI4920 30 mg | Biological | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
|
| MEDI4920 100 mg | Biological | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
|
| MEDI4920 300 mg | Biological | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
|
| MEDI4920 1000 mg | Biological | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
|
| MEDI4920 3000 mg | Biological | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
| Placebo | Other | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
|
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920 | 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. | 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 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920 | 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. | 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 |
| Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920 | 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. | 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 |
| Terminal Elimination Half Life (t1/2) of MEDI4920 | 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. | 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 |
| Systemic Clearance (CL) of MEDI4920 | 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. | 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 |
| Volume of Distribution at Steady-state (Vss) of MEDI4920 | 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. | 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 |
| Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920 | 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. | 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 |
| Percentage of Participants Positive for Anti-drug Antibodies (ADA) | Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented. | Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first |
| T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration | 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. | Day 43 |
| FG002 | MEDI4920 10 mg | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
| FG003 | MEDI4920 30 mg | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| FG004 | MEDI4920 100 mg | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| FG005 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| FG006 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| FG007 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
As-treated population included all participants who received any study drug. Two participants were erroneously randomized to MEDI4920 10 mg group due to the IXRS system not being opened for start of MEDI4920 30 mg group. However, these participants received the 30 mg dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
| BG001 | MEDI4920 3 mg | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
| BG002 | MEDI4920 10 mg | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
| BG003 | MEDI4920 30 mg | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| BG004 | MEDI4920 100 mg | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| BG005 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| BG006 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| BG007 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| BG008 | TOTAL | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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. | As-treated Population: All participants who received any study drug were included in this population | Posted | Count of Participants | Participants | The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | microgram per milliliter (µg/mL) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | microgram*day per milliliter (µg*d/mL) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | microgram*day per milliliter (µg*d/mL) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | µg*d/mL/mg | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Half Life (t1/2) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | Day(s) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Systemic Clearance (CL) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | milliliter per day (mL/day) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady-state (Vss) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | milliliter (mL) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920 | 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. | As-treated Population | Posted | Mean | Standard Deviation | milliliter (mL) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Anti-drug Antibodies (ADA) | Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented. | As-treated Population. | Posted | Number | Percentage of participants | Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration | 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. | As-treated Population. | Posted | Geometric Mean | 95% Confidence Interval | nanogram per milliliter (ng/mL) | Day 43 |
|
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).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG001 | MEDI4920 3 mg | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | MEDI4920 10 mg | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | MEDI4920 30 mg | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | MEDI4920 100 mg | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG006 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG007 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. | 0 | 8 | 0 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Howe, MBChB, MD, MRCOG | MedImmune LLC | +44 (0) 1223 895980 | information.center@astrazenea.com |
| Male |
|
| TESAEs |
|
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
| MEDI4920 100 mg |
Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
|
|
| OG004 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG005 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG006 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
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| OG004 |
| MEDI4920 100 mg |
Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| OG005 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG006 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG007 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
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|
| OG003 | MEDI4920 30 mg | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| OG004 | MEDI4920 100 mg | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| OG005 | MEDI4920 300 mg | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| OG006 | MEDI4920 1000 mg | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| OG007 | MEDI4920 3000 mg | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
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|