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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo intramuscularly. |
|
| MEDI8897 10 mg | Experimental | Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. |
|
| MEDI8897 25 mg | Experimental | Participants will receive a single dose of MEDI8897 25 mg intramuscularly. |
|
| MEDI8897 50 mg | Experimental | Participants will receive a single dose of MEDI8897 50 mg intramuscularly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive placebo intramuscularly. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any 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. | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) |
| 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. | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) |
| 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. | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| Maximum Observed Serum Concentration (Cmax) of MEDI8897 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | United States | |||
| Research Site |
A total of 151 participants were screened in the study, of which 89 participants were randomized and treated.
Participants were recruited between January 2015 and September 2015 at 10 sites (USA, South Africa, and Chile) and followed for 1 year after dosing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo intramuscularly. |
| FG001 | MEDI8897 10 mg | Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MEDI8897 10 mg |
| Drug |
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly. |
|
| MEDI8897 25 mg | Drug | Participants will receive a single dose of MEDI8897 25 mg intramuscularly. |
|
| MEDI8897 50 mg | Drug | Participants will receive a single dose of MEDI8897 50 mg intramuscularly. |
|
The Cmax is the maximum observed serum concentration of MEDI8897. |
| Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| 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). | 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 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
| 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. | Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose |
| Ontario |
| California |
| United States |
| Research Site | Syracuse | New York | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | St. George | Utah | United States |
| Research Site | Marshfield | Wisconsin | United States |
| Research Site | Santiago | Chile |
| Research Site | Valdivia | Chile |
| Research Site | Cape Town | South Africa |
| Research Site | East London | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Pretoria | South Africa |
| FG002 | MEDI8897 25 mg | Participants received a single dose of MEDI8897 25 mg intramuscularly. |
| FG003 | MEDI8897 50 mg | Participants received a single dose of MEDI8897 50 mg intramuscularly. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The As-treated Population included all participants who received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo intramuscularly. |
| BG001 | MEDI8897 10 mg | Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly. |
| BG002 | MEDI8897 25 mg | Participants received a single dose of MEDI8897 25 mg intramuscularly. |
| BG003 | MEDI8897 50 mg | Participants received a single dose of MEDI8897 50 mg intramuscularly. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any 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. | The As-treated Population included all participants who received any study drug. | Posted | Count of Participants | Participants | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) |
|
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. | Posted | Count of Participants | Participants | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361) |
| |||||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. | Posted | Count of Participants | Participants | From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151) |
| |||||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Day | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) of MEDI8897 | The Cmax is the maximum observed serum concentration of MEDI8897. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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). | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Day*mcg/mL | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Day*mcg/mL | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Day | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | mL/day | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | mL | Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose |
|
| |||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included participants who received any study drug. | Posted | Count of Participants | Participants | Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose |
|
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo intramuscularly. | 0 | 18 | 0 | 18 | 17 | 18 |
| EG001 | MEDI8897 10 mg | Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | MEDI8897 25 mg | Participants received a single dose of MEDI8897 25 mg intramuscularly. | 0 | 31 | 1 | 31 | 31 | 31 |
| EG003 | MEDI8897 50 mg | Participants received a single dose of MEDI8897 50 mg intramuscularly. | 0 | 32 | 2 | 32 | 28 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Pamela Griffin | MedImmune, LLC | 301-398-4095 | information.center@astrazeneca.com |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| TESAEs |
|
| MEDI8897 50 mg |
Participants received a single dose of MEDI8897 50 mg intramuscularly. |
|
|
Participants received a single dose of MEDI8897 50 mg intramuscularly.
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| Participants |
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| Units | Counts |
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| Participants |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
|---|---|
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