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The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motavizumab, 3 mg/kg as a single intravenous dose | Experimental | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
|
| Motavizumab, 15 mg/kg as a single intravenous dose | Experimental | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
|
| Motavizumab, 30 mg/kg as a single intravenous dose | Experimental | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
|
| Placebo, as a single intravenous dose | Placebo Comparator | Placebo, as a single intravenous dose administered on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motavizumab | Biological | Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Adverse Events Through 30 Days After Dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing | From the start of treatment to 30 days after dosing |
| Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing | From the start of treatment to 30 days after dosing |
| The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations | Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing | From the start of treatment to 30 days after dosing |
| To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 | Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA). | Day 2 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. | Immediately before dosing on Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Genevieve A Losonsky, MD | MedImmune LLC | Study Director |
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The screening period occurred within 24 hours before randomization. All subjects who were screened were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motavizumab (MEDI-524), 3 mg/kg | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| FG001 | Motavizumab (MEDI-524), 15 mg/kg | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
| FG002 | Motavizumab (MEDI-524), 30 mg/kg | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| FG003 | Placebo | Placebo, as a single intravenous dose administered on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Motavizumab (MEDI-524), 3 mg/kg | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| BG001 | Motavizumab (MEDI-524), 15 mg/kg | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at randomization |
| 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 Subjects Reporting Adverse Events Through 30 Days After Dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing | All patients who recieved study drug were included in the analysis of safety. | Posted | Number | Participants | From the start of treatment to 30 days after dosing |
|
Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
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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 | Motavizumab (MEDI-524), 3 mg/kg | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epstein-Barr virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Genevieve A. Losonsky, MD/VP Clinical Development | MedImmune, LLC | 301-398-0000 | losonskyG@medimmune.com |
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| ID | Term |
|---|---|
| C506968 | motavizumab |
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|
| Motavizumab | Biological | Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0 |
|
|
| Motavizumab | Biological | Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0 |
|
|
| Placebo | Other | Single dose of placebo administered intravenously (in the vein) on Day 0 |
|
| To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30 |
The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. |
| Day 30 |
| Dosing window missed |
|
| BG002 | Motavizumab (MEDI-524), 30 mg/kg | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| BG003 | Placebo | Placebo, as a single intravenous dose administered on Day 0 |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| months |
|
| Sex: Female, Male | Baseline demographics are not available for one patient in the 30 mg/kg group because the patient received no study drug in the study. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| OG002 | Motavizumab (MEDI-524), 30 mg/kg | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| OG003 | Placebo | Placebo, as a single intravenous dose administered on Day 0 |
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing | Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing | Posted | Number | participants | From the start of treatment to 30 days after dosing |
|
|
|
| Secondary | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 | The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. | All patients who received a full dose of study drug were included in the analysis of immunogenicity. | Posted | Number | Participants | Immediately before dosing on Day 0 |
|
|
|
| Secondary | To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30 | The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay. | All patients who received a full dose of study drug were included in the analysis of immunogenicity. One patient in the 3 mg/kg group was not assessed for immunogenicity. | Posted | Number | Participants | Day 30 |
|
|
|
| Primary | The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations | Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing | All patients who recieved study drug were included in the analysis of safety. | Posted | Number | Participants | From the start of treatment to 30 days after dosing |
|
|
|
| Primary | To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 | Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA). | All patients who recieved a full dose of study drug were included in the analysis of trough serum concentrations. One patient in the 3 mg/kg group was not assessed for serum trough levels at either Day 2 or Day 30. | Posted | Mean | Standard Deviation | Micrograms per mililiter | Day 2 and Day 30 |
|
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Motavizumab (MEDI-524), 15 mg/kg | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 | 0 | 5 | 5 | 5 |
| EG002 | Motavizumab (MEDI-524), 30 mg/kg | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 | 1 | 5 | 3 | 5 |
| EG003 | Placebo | Placebo, as a single intravenous dose administered on Day 0 | 1 | 15 | 6 | 15 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Disbacteriosis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Genital infection fungal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Haemodynamic instability | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pseudomonal bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Superinfection bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral skin infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Trough Serum Concentration at Day 30 |
|