Respiratory Syncytial Virus
Conditions
Keywords
Respiratory Syncytial Virus, RSV
Brief summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.
Detailed description
This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.
Interventions
DRUGPlacebo
Participants will receive placebo intramuscularly.
DRUGMEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
DRUGMEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
DRUGMEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age * Infants who are entering their first RSV season at the time of screening Key
Exclusion criteria
* Gestational age \< 32 weeks 0 days and \>34 weeks 6 days * Meets AAP or other local criteria to receive commercial palivizumab * Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization * Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization * Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection * Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) | An adverse event (AE) is any unfavorable 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/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state. |
| Number of Participants With Treatment-Emergent Adverse Events of Special Interest | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) | An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose. |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151) | Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897. |
| Terminal Elimination Half Life (t1/2) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed. |
| Extravascular Volume of Distribution (Vz/F) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | 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 serum concentration of a drug. |
| Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose | A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive. |
| Extravascular Clearance (CL/F) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Maximum Observed Serum Concentration (Cmax) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose | The Cmax is the maximum observed serum concentration of MEDI8897. |
| Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose | Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151). |
Countries
Chile, South Africa, United States
Participant flow
Recruitment details
Participants were recruited between January 2015 and September 2015 at 10 sites (USA, South Africa, and Chile) and followed for 1 year after dosing.
Pre-assignment details
A total of 151 participants were screened in the study, of which 89 participants were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo intramuscularly. | 18 |
| MEDI8897 10 mg Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly. | 8 |
| MEDI8897 25 mg Participants received a single dose of MEDI8897 25 mg intramuscularly. | 31 |
| MEDI8897 50 mg Participants received a single dose of MEDI8897 50 mg intramuscularly. | 32 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | MEDI8897 50 mg | MEDI8897 25 mg | MEDI8897 10 mg |
|---|---|---|---|---|---|
| Age, Continuous | 7.0 Months STANDARD_DEVIATION 2.6 | 6.6 Months STANDARD_DEVIATION 2.6 | 6.9 Months STANDARD_DEVIATION 2.5 | 6.7 Months STANDARD_DEVIATION 2.7 | 4.2 Months STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 51 Participants | 21 Participants | 19 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 22 Participants | 7 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 12 Participants | 2 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Female | 11 Participants | 53 Participants | 19 Participants | 19 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 36 Participants | 13 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 8 | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 17 / 18 | 5 / 8 | 31 / 31 | 28 / 32 |
| serious Total, serious adverse events | 0 / 18 | 0 / 8 | 1 / 31 | 2 / 32 |
Outcome results
Primary
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.
Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
Population: The As-treated Population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Anaemia | 6 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Neutropenia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Microcytic anaemia | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Anaemia | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Neutropenia | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Microcytic anaemia | 0 Participants |
| MEDI8897 25 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Microcytic anaemia | 0 Participants |
| MEDI8897 25 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Anaemia | 8 Participants |
| MEDI8897 25 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Neutropenia | 0 Participants |
| MEDI8897 50 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Anaemia | 4 Participants |
| MEDI8897 50 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Neutropenia | 1 Participants |
| MEDI8897 50 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events | Microcytic anaemia | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events of Special Interest
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.
Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Population: The As-treated Population included all participants who received any study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events of Special Interest | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest | 0 Participants |
| MEDI8897 25 mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest | 0 Participants |
| MEDI8897 50 mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any unfavorable 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/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Population: The As-treated Population included all participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 17 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| MEDI8897 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 Participants |
| MEDI8897 25 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 31 Participants |
| MEDI8897 25 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 Participants |
| MEDI8897 50 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 30 Participants |
| MEDI8897 50 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 Participants |
Secondary
Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 | 1940 Day*mcg/mL | Standard Deviation 809 |
| MEDI8897 10 mg | Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 | 2260 Day*mcg/mL | Standard Deviation 881 |
| MEDI8897 25 mg | Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 | 5470 Day*mcg/mL | Standard Deviation 1440 |
Secondary
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 | 2450 Day*mcg/mL | — |
| MEDI8897 10 mg | Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 | 4320 Day*mcg/mL | Standard Deviation 1070 |
| MEDI8897 25 mg | Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 | 7510 Day*mcg/mL | Standard Deviation 1870 |
Secondary
Extravascular Clearance (CL/F) of MEDI8897
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extravascular Clearance (CL/F) of MEDI8897 | 4.08 mL/day | — |
| MEDI8897 10 mg | Extravascular Clearance (CL/F) of MEDI8897 | 6.05 mL/day | Standard Deviation 1.31 |
| MEDI8897 25 mg | Extravascular Clearance (CL/F) of MEDI8897 | 7.01 mL/day | Standard Deviation 1.57 |
Secondary
Extravascular Volume of Distribution (Vz/F) of MEDI8897
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 serum concentration of a drug.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extravascular Volume of Distribution (Vz/F) of MEDI8897 | 429 mL | — |
| MEDI8897 10 mg | Extravascular Volume of Distribution (Vz/F) of MEDI8897 | 581 mL | Standard Deviation 159 |
| MEDI8897 25 mg | Extravascular Volume of Distribution (Vz/F) of MEDI8897 | 633 mL | Standard Deviation 168 |
Secondary
Maximum Observed Serum Concentration (Cmax) of MEDI8897
The Cmax is the maximum observed serum concentration of MEDI8897.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) of MEDI8897 | 23.2 microgram per milliliter (mcg/mL) | Standard Deviation 9.28 |
| MEDI8897 10 mg | Maximum Observed Serum Concentration (Cmax) of MEDI8897 | 30.9 microgram per milliliter (mcg/mL) | Standard Deviation 10.4 |
| MEDI8897 25 mg | Maximum Observed Serum Concentration (Cmax) of MEDI8897 | 71.7 microgram per milliliter (mcg/mL) | Standard Deviation 15.9 |
Secondary
Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
Population: The As-treated Population included participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Baseline | 1 Participants |
| Placebo | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 31 | 0 Participants |
| Placebo | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 151 | 0 Participants |
| Placebo | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 361 | 0 Participants |
| MEDI8897 10 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 31 | 2 Participants |
| MEDI8897 10 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 151 | 0 Participants |
| MEDI8897 10 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 361 | 1 Participants |
| MEDI8897 10 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Baseline | 0 Participants |
| MEDI8897 25 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 151 | 0 Participants |
| MEDI8897 25 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 31 | 0 Participants |
| MEDI8897 25 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 361 | 7 Participants |
| MEDI8897 25 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Baseline | 0 Participants |
| MEDI8897 50 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 361 | 10 Participants |
| MEDI8897 50 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 31 | 0 Participants |
| MEDI8897 50 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Baseline | 0 Participants |
| MEDI8897 50 mg | Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 | Day 151 | 0 Participants |
Secondary
Terminal Elimination Half Life (t1/2) of MEDI8897
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Terminal Elimination Half Life (t1/2) of MEDI8897 | 72.9 Day | — |
| MEDI8897 10 mg | Terminal Elimination Half Life (t1/2) of MEDI8897 | 66.2 Day | Standard Deviation 7.83 |
| MEDI8897 25 mg | Terminal Elimination Half Life (t1/2) of MEDI8897 | 62.5 Day | Standard Deviation 9.35 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
Time frame: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Population: The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 7.04 Day | Standard Deviation 0.0683 |
| MEDI8897 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 7.04 Day | Standard Deviation 0.394 |
| MEDI8897 25 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 6.93 Day | Standard Deviation 0.549 |