RSV Infection
Conditions
Keywords
Respiratory Syncytial Virus (RSV), Healthy adults, MEDI-557, Intranasal challenge, Human model
Brief summary
The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.
Detailed description
This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Participants will be inoculated with RSV-A. Participants will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.
Interventions
DRUGPlacebo
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
DRUGMEDI-557
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy as determined by medical history and physical examination. 2. Age 19 through 38 years at the time of screening. 3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 4. Weight less than or equal to (\<=) 10 kilogram (kg) with body mass index (BMI) less than (\<) 32 kilogram per meter square (kg/m\^2). 5. Normotensive (systolic blood pressure \[BP\] \<150 millimeters of mercury (mmHg) and diastolic BP \< 90 mmHg). 6. Females of childbearing age using contraception. 7. Males who are sexually active with a female partner of childbearing potential, using contraception. 8. Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.
Exclusion criteria
Current medical conditions as follows: 1. Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication. 2. Current smoker unwilling/unable to desist for the quarantine phase of the study. 3. History or clinical evidence of recurrent lower respiratory tract infection. 4. Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology. Medical history as follows: 5. History of immunodeficiency. 6. History of chronic sinusitis. 7. History of frequent epistaxis. 8. History of or current diagnosis of diabetes. 9. Prior/concomitant therapy including * Receipt of any systemic chemotherapeutic agent at any time; * Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge. * Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study. * Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose. 10. Nursing mother. 11. Alcohol or drug addiction/abuse within the past 2 years. 12. A positive urine Class A drug or alcohol screen unless there is a medical reason. 13. History of seasonal hay fever or seasonal allergies. 14. Employees of the clinical study site or sponsor, any other individuals involved with the conduct of the study, or immediate family members of such individuals. 15. Health care workers anticipated to have patient contact within 2 weeks after viral challenge. 16. Participants who, for an additional 2 weeks after discharge from the isolation facility, are likely to have contact with a household member or close contact with someone who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition; or (f) any person who has received a transplant (bone marrow or solid organ). 17. As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the participant unfit for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture | From Day 4 to Day 15 | RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Viral Load AUC0-t by Plaque Assay Culture | From Day 5 through Day 31 | RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge. |
| Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | From Day 5 through Day 31 | RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge. |
| Mean Nasal RSV Peak as Measured by Plaque Assay Culture | From Day 5 through Day 31 | RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter. |
| Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | From Day 5 through Day 31 | RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge. |
| Duration of Respiratory Syncytial Virus (RSV) Viral Shedding | From Day 5 through Day 31 | Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay. |
| Mean Serum MEDI-557 Concentration Through Day 360 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | MEDI-557 serum concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum\]. |
| Maximum Serum Concentration (Cmax) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | The Cmax is the maximum observed serum concentration of MEDI-557. |
| Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration. |
| Serum Half Life (t1/2) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | Serum decay half-life is the time measured for the serum concentration to decrease by one half. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | 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 plasma 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. |
| Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | From Day 4 to Day 15 | RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml \>= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for \>= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for \>=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for \>=2 consecutive days through 12 days post-RSV challenge. |
| Mean Clearance of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]). |
| Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31 | MEDI-557 nasal wash concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash\]. |
| Maximum Nasal Wash Concentration (Cmax) of MEDI-557 | Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31 | The Cmax is the maximum observed nasal wash concentration of MEDI-557. |
| Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557 | Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31 | The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration. |
| Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557 | Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31 | The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'. |
| Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose | Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From Day 1 (immediately following administration of study drug) to Day 360 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs) | From Day 1 through Day 31 | Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported. |
| Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | From Day 1 through Day 91 | Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported. |
| Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values | Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31 | Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values. |
| Volume of Distribution at Steady-State (Vss) of MEDI-557 | Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360 | Volume of distribution 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 drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-infinity\])\*(AUMC\[0-infinity\])/AUC\[0-infinity\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 90 participants were screened, out of these, 7 participants were randomized and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3. | 4 |
| MEDI-557 Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Placebo | MEDI-557 | Total |
|---|---|---|---|
| Age, Continuous | 24.5 Years STANDARD_DEVIATION 4.4 | 28.0 Years STANDARD_DEVIATION 9.5 | 26.0 Years STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 1 / 4 | 0 / 3 |
Outcome results
Primary
Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture
RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL.
Time frame: From Day 4 to Day 15
Population: Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture | 66.7 percentage of participants |
| MEDI-557 | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture | 0.0 percentage of participants |
95% CI: [0, 2.05]
Secondary
Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557
The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.
Time frame: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557 | 4541.3636 day*nanogram per milliliter (d*ng/ml) | Standard Deviation 3905.7874 |
Secondary
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557
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 plasma 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.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557 | 37266.5740 d*mcg/ml | Standard Deviation 1764.707 |
Secondary
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557
The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557 | 34484.8642 day*microgram per milliliter (d*mcg/ml) | Standard Deviation 1114.4471 |
Secondary
Duration of Respiratory Syncytial Virus (RSV) Viral Shedding
Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.
Time frame: From Day 5 through Day 31
Population: Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Respiratory Syncytial Virus (RSV) Viral Shedding | 10.0 days | Full Range 0 |
| MEDI-557 | Duration of Respiratory Syncytial Virus (RSV) Viral Shedding | 6.5 days | Full Range 4.5 |
Secondary
Maximum Nasal Wash Concentration (Cmax) of MEDI-557
The Cmax is the maximum observed nasal wash concentration of MEDI-557.
Time frame: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Nasal Wash Concentration (Cmax) of MEDI-557 | 377.9800 nanogram per milliliter (ng/ml) | Standard Deviation 212.2542 |
Secondary
Maximum Serum Concentration (Cmax) of MEDI-557
The Cmax is the maximum observed serum concentration of MEDI-557.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Serum Concentration (Cmax) of MEDI-557 | 504.0433 microgram per milliliter (mcg/ml) | Standard Deviation 6.6189 |
Secondary
Mean Clearance of MEDI-557
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]).
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Clearance of MEDI-557 | 50.3831 milliliter per day (ml/d) | Standard Deviation 4.6158 |
Secondary
Mean Nasal RSV Peak as Measured by Plaque Assay Culture
RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.
Time frame: From Day 5 through Day 31
Population: Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \>= 1 day through 12 days post-RSV challenge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Nasal RSV Peak as Measured by Plaque Assay Culture | 4.150 log10 pfu/mL | Standard Deviation 0.521 |
Secondary
Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge.
Time frame: From Day 5 through Day 31
Population: Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \>= 2 consecutive days through 12 days post-RSV challenge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | 7.700 log10 copies/mL | Standard Deviation 0.453 |
| MEDI-557 | Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | 4.260 log10 copies/mL | Standard Deviation 0.863 |
Secondary
Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points
MEDI-557 nasal wash concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash\].
Time frame: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 1 (pre-dose) | 0.000 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 2 | 166.613 nanogram per milliliter (ng/mL) | Standard Deviation 8.257 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 5 | 192.827 nanogram per milliliter (ng/mL) | Standard Deviation 160.257 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 6 | 189.767 nanogram per milliliter (ng/mL) | Standard Deviation 87.745 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 7 | 227.980 nanogram per milliliter (ng/mL) | Standard Deviation 189.806 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 8 | 308.153 nanogram per milliliter (ng/mL) | Standard Deviation 173.823 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 9 | 201.647 nanogram per milliliter (ng/mL) | Standard Deviation 105.288 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 10 | 132.407 nanogram per milliliter (ng/mL) | Standard Deviation 134.702 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 11 | 220.953 nanogram per milliliter (ng/mL) | Standard Deviation 58.505 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 12 | 262.800 nanogram per milliliter (ng/mL) | Standard Deviation 310.692 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 13 | 89.867 nanogram per milliliter (ng/mL) | Standard Deviation 72.249 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 14 | 184.747 nanogram per milliliter (ng/mL) | Standard Deviation 260.718 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 15 | 243.567 nanogram per milliliter (ng/mL) | Standard Deviation 251.884 |
| Placebo | Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points | Day 31 | 62.707 nanogram per milliliter (ng/mL) | Standard Deviation 62.348 |
Secondary
Mean Serum MEDI-557 Concentration Through Day 360
MEDI-557 serum concentrations were summarized by each sampling point \[LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum\].
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 1 (pre-dose) (n=3) | 0.000 microgram per milliliter (ug/mL) | Standard Deviation 0 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | 1 hr Post-dose (n=3) | 498.730 microgram per milliliter (ug/mL) | Standard Deviation 6.615 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | 4 hr Post-dose (n=3) | 462.937 microgram per milliliter (ug/mL) | Standard Deviation 40.212 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | 8 hr Post-dose (n=3) | 458.413 microgram per milliliter (ug/mL) | Standard Deviation 40.613 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 2 (n=3) | 407.627 microgram per milliliter (ug/mL) | Standard Deviation 13.42 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 3 (n=3) | 343.283 microgram per milliliter (ug/mL) | Standard Deviation 48.078 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 5 (n=3) | 298.020 microgram per milliliter (ug/mL) | Standard Deviation 48.966 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 7 (n=3) | 287.917 microgram per milliliter (ug/mL) | Standard Deviation 39.276 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 9 (n=3) | 293.897 microgram per milliliter (ug/mL) | Standard Deviation 33.128 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 11(n=3) | 265.107 microgram per milliliter (ug/mL) | Standard Deviation 24.076 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 15 (n=3) | 252.327 microgram per milliliter (ug/mL) | Standard Deviation 16.091 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 31 (n=3) | 252.177 microgram per milliliter (ug/mL) | Standard Deviation 23.225 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 61 (n=2) | 180.505 microgram per milliliter (ug/mL) | Standard Deviation 6.442 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 91 (n=3) | 131.053 microgram per milliliter (ug/mL) | Standard Deviation 4.571 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 120 (n=3) | 106.040 microgram per milliliter (ug/mL) | Standard Deviation 10.023 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 150 (n=3) | 75.583 microgram per milliliter (ug/mL) | Standard Deviation 11.258 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 180 (n=3) | 65.443 microgram per milliliter (ug/mL) | Standard Deviation 5.897 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 240 (n=2) | 43.875 microgram per milliliter (ug/mL) | Standard Deviation 6.428 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 300 (n=3) | 31.353 microgram per milliliter (ug/mL) | Standard Deviation 5.731 |
| Placebo | Mean Serum MEDI-557 Concentration Through Day 360 | Day 360 (n=3) | 20.343 microgram per milliliter (ug/mL) | Standard Deviation 4.138 |
Secondary
Mean Viral Load AUC0-t by Plaque Assay Culture
RSV infection by plaque assay culture defined as positive sample for \>= 1 day through 12 days post-RSV challenge.
Time frame: From Day 5 through Day 31
Population: Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for \>=1 day through 12 days post-RSV challenge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Viral Load AUC0-t by Plaque Assay Culture | 42.165 log10 pfu*day/mL | Standard Deviation 3.305 |
Secondary
Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
RSV infection by plaque assay culture defined as positive sample for \>= 2 consecutive days through 12 days post-RSV challenge.
Time frame: From Day 5 through Day 31
Population: Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for \>= 2 consecutive days through 12 days post-RSV challenge).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | 100.04 log10 copies*day/mL | Standard Deviation 7 |
| MEDI-557 | Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) | 65.708 log10 copies*day/mL | Standard Deviation 1.488 |
Secondary
Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.
Time frame: From Day 1 through Day 91
Population: Safety Population included all participants who received any amount of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Coagulation | 0 participants |
| Placebo | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Urinalysis | 0 participants |
| Placebo | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Serum chemistry | 0 participants |
| Placebo | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Cardiac enzymes | 1 participants |
| Placebo | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Hematology | 0 participants |
| MEDI-557 | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Cardiac enzymes | 0 participants |
| MEDI-557 | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Hematology | 0 participants |
| MEDI-557 | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Coagulation | 0 participants |
| MEDI-557 | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Serum chemistry | 2 participants |
| MEDI-557 | Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs) | Urinalysis | 2 participants |
Secondary
Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values
Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.
Time frame: Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31
Population: Safety Population included all participants who received any amount of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values | 0 participants |
| MEDI-557 | Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Day 1 (immediately following administration of study drug) to Day 360
Population: Safety Population included all participants who received any amount of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 4 participants |
| MEDI-557 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 0 participants |
| MEDI-557 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 3 participants |
Secondary
Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)
Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.
Time frame: From Day 1 through Day 31
Population: Safety Population included all participants who received any amount of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs) | 3 participants |
| MEDI-557 | Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs) | 3 participants |
Secondary
Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method
RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml \>= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for \>= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for \>=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for \>= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for \>=2 consecutive days through 12 days post-RSV challenge.
Time frame: From Day 4 to Day 15
Population: Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by quantitative real-time RT-PCR | 66.7 percentage of participants |
| Placebo | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by DFA | 66.7 percentage of participants |
| Placebo | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by Any Method | 66.7 percentage of participants |
| MEDI-557 | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by quantitative real-time RT-PCR | 66.7 percentage of participants |
| MEDI-557 | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by DFA | 0.0 percentage of participants |
| MEDI-557 | Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method | RSV infection by Any Method | 66.7 percentage of participants |
Comparison: RSV infection by quantitative real-time RT-PCR95% CI: [0.16, 6.24]
Comparison: RSV infection by DFA95% CI: [0, 2.05]
Comparison: RSV infection by Any Method95% CI: [0.16, 6.24]
Secondary
Percentage of Participants With Positive Anti-MEDI-557 Antibodies
Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.
Time frame: Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose
Population: Population for ADA included all participants who received any amount of investigational product and had \>= 1 post-baseline measurement for ADA. Here, n is number of participants analysed at specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 1 (pre-dose) (n=4,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 31 (n=4,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 91 (n=4,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 150 (n=3,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 180 (n=4,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 240 (n=3,2) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 300 (n=4,3) | 0 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 360 (n=4,3) | 0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 360 (n=4,3) | 0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 1 (pre-dose) (n=4,3) | 0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 180 (n=4,3) | 66.7 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 31 (n=4,3) | 0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 300 (n=4,3) | 33.3 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 91 (n=4,3) | 0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 240 (n=3,2) | 50.0 percentage of participants |
| MEDI-557 | Percentage of Participants With Positive Anti-MEDI-557 Antibodies | Day 150 (n=3,3) | 33.3 percentage of participants |
Secondary
Serum Half Life (t1/2) of MEDI-557
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Half Life (t1/2) of MEDI-557 | 94.0029426 Day | Standard Deviation 93.8412056 |
Secondary
Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557
The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.
Time frame: Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557 | 9.051 Day | Standard Deviation 2.113 |
Secondary
Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557
The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557 | 0.162 Day | Standard Deviation 0.068 |
Secondary
Volume of Distribution at Steady-State (Vss) of MEDI-557
Volume of distribution 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 drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC\[0-infinity\])\*(AUMC\[0-infinity\])/AUC\[0-infinity\]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.
Time frame: Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360
Population: Population for PK included all participants who received a full dose of investigational product and had \>= 1 post-baseline measurement for PK.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Volume of Distribution at Steady-State (Vss) of MEDI-557 | 6644.3433 milliliter (ml) | Standard Deviation 606.4269 |