Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus, RSV
Brief summary
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.
Detailed description
This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.
Interventions
DRUGMEDI8897 Intravenous
Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
DRUGPlacebo
Participants received placebo on Day 1.
DRUGMEDI8897 Intramuscular
Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Age 18 through 49 years and in good health by history, physical exam, and labs * Weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at Screening * Written informed consent prior to performing any protocol related procedures, including Screening evaluations * Ability to complete the Follow-up period of 360 days Key
Exclusion criteria
* Acute illness including fever \>= 99.5 Fahrenheit (°F) on day of dosing * Any drug therapy within 7 days prior to Day 1 (except contraceptives) * Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing * Previous receipt of a monoclonal antibody (mAb) * Pregnant or nursing mother * Concurrent enrollment in another interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration up to Day 391 (Day 361 +/- 30 days) | An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) for MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Volume of Distribution (Vz) for MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
| Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose and Day 15, 31, 91, 181, 271 and 361 | Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose. |
| Systemic Clearance (CL) for MEDI8897 | Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361 | Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation). |
Countries
United States
Participant flow
Pre-assignment details
There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo on Day 1. | 34 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | 6 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | 6 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | 6 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | 6 |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. | 78 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 | 1 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawn by site due to noncompliance | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.2 Years STANDARD_DEVIATION 8.6 | 34.5 Years STANDARD_DEVIATION 8.6 | 34.3 Years STANDARD_DEVIATION 5.6 | 33.5 Years STANDARD_DEVIATION 6.7 | 30.7 Years STANDARD_DEVIATION 7.8 | 30.3 Years STANDARD_DEVIATION 7.9 | 30.5 Years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 19 Participants | 4 Participants | 2 Participants | 3 Participants | 6 Participants | 39 Participants | 73 Participants |
| Sex: Female, Male Male | 15 Participants | 2 Participants | 4 Participants | 3 Participants | 0 Participants | 39 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 34 | 3 / 6 | 3 / 6 | 5 / 6 | 4 / 6 | 48 / 78 |
| serious Total, serious adverse events | 0 / 34 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 2 / 78 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Time frame: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
Population: The As-treated population included participants who receive any study 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 | 21 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 3 participants |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 3 participants |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 4 participants |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 48 participants |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 participants |
Secondary
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | 6714.75 Day*microgram per milliliter | Standard Deviation 21.7 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | 25320.68 Day*microgram per milliliter | Standard Deviation 17 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | 63580.33 Day*microgram per milliliter | Standard Deviation 10.4 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | 2249.11 Day*microgram per milliliter | Standard Deviation 17.9 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897 | 5193.73 Day*microgram per milliliter | Standard Deviation 32.1 |
Secondary
Maximum Observed Serum Concentration (Cmax) for MEDI8897
The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) for MEDI8897 | 96.98 microgram per milliliter (mcg/ml) | Standard Deviation 21.9 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Maximum Observed Serum Concentration (Cmax) for MEDI8897 | 333.80 microgram per milliliter (mcg/ml) | Standard Deviation 22.4 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Maximum Observed Serum Concentration (Cmax) for MEDI8897 | 1163.32 microgram per milliliter (mcg/ml) | Standard Deviation 23.8 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Maximum Observed Serum Concentration (Cmax) for MEDI8897 | 20.40 microgram per milliliter (mcg/ml) | Standard Deviation 29.4 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Maximum Observed Serum Concentration (Cmax) for MEDI8897 | 47.48 microgram per milliliter (mcg/ml) | Standard Deviation 26.2 |
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA)
Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.
Time frame: Predose and Day 15, 31, 91, 181, 271 and 361
Population: The As-treated Population included participants who receive any study investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 3 participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 5 participants |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 0 participants |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 0 participants |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 0 participants |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 1 participants |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 0 participants |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 0 participants |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 0 participants |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 0 participants |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | Number of Participants With Positive Anti-Drug Antibody (ADA) | Predose | 5 participants |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | Number of Participants With Positive Anti-Drug Antibody (ADA) | At Any Time Postdose | 13 participants |
Secondary
Systemic Clearance (CL) for MEDI8897
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC\[0-infinity\]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systemic Clearance (CL) for MEDI8897 | 46.05 ml per day | Standard Deviation 17.3 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Systemic Clearance (CL) for MEDI8897 | 40.33 ml per day | Standard Deviation 15.4 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Systemic Clearance (CL) for MEDI8897 | 47.60 ml per day | Standard Deviation 10.6 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Systemic Clearance (CL) for MEDI8897 | 45.46 ml per day | Standard Deviation 15.4 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Systemic Clearance (CL) for MEDI8897 | 64.60 ml per day | Standard Deviation 37.7 |
Secondary
Terminal Phase Elimination Half Life (t1/2) for MEDI8897
The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | 116.52 Day | Standard Deviation 19.6 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | 92.0 Day | Standard Deviation 12.6 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | 89.81 Day | Standard Deviation 18.2 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | 102.61 Day | Standard Deviation 11.3 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Terminal Phase Elimination Half Life (t1/2) for MEDI8897 | 85.29 Day | Standard Deviation 30.8 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 0.078 Day | Standard Deviation 172 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 0.059 Day | Standard Deviation 0 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 0.209 Day | Standard Deviation 62.7 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 5.46 Day | Standard Deviation 71.4 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 | 9.42 Day | Standard Deviation 78.4 |
Secondary
Volume of Distribution (Vz) for MEDI8897
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Population: Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Volume of Distribution (Vz) for MEDI8897 | 7694.15 milliliter (ml) | Standard Deviation 24.8 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | Volume of Distribution (Vz) for MEDI8897 | 5426.89 milliliter (ml) | Standard Deviation 26.7 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | Volume of Distribution (Vz) for MEDI8897 | 6137.69 milliliter (ml) | Standard Deviation 18.5 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | Volume of Distribution (Vz) for MEDI8897 | 6808.78 milliliter (ml) | Standard Deviation 24.5 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | Volume of Distribution (Vz) for MEDI8897 | 7455.90 milliliter (ml) | Standard Deviation 34 |