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This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 1 MG/KG | Experimental | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 3 MG/KG | Experimental | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 10 MG/KG | Experimental | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 20 MG/KG | Experimental | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting 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. A serious adverse event (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 administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Day 1 to Day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameters of MEDI7814 | Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed. | Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Marion, MD | Research site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Omaha | Nebraska | United States |
Out of 125 participants enrolled, 32 participants were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| FG001 | MEDI7814, 1 MG/KG | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
| FG002 | MEDI7814, 3 MG/KG | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| FG003 | MEDI7814, 10 MG/KG | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| FG004 | MEDI7814, 20 MG/KG | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| BG001 | MEDI7814, 1 MG/KG | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Reporting 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. A serious adverse event (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 administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Safety population included all randomized participants who received MEDI7814 and had safety data available. | Posted | Number | Participants | Day 1 to Day 106 |
|
Day 1 to Day 106
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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 | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 15.0 | Systematic Assessment |
Analyses of PK parameters and immunogenicity were not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph M. Parker, Director, Clinical Development | MedImmune, LLC. | 301-398-0000 | parkerj@medimmune.com |
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| MEDI7814, 1 MG/KG | Biological | A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 3 MG/KG | Biological | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 10 MG/KG | Biological | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| MEDI7814, 20 MG/KG | Biological | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
| Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 | Day 1, 29, 57, 85, and 106 |
| BG002 | MEDI7814, 3 MG/KG | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| BG003 | MEDI7814, 10 MG/KG | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| BG004 | MEDI7814, 20 MG/KG | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| BG005 | TOTAL | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| OG001 | MEDI7814, 1 MG/KG | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
| OG002 | MEDI7814, 3 MG/KG | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| OG003 | MEDI7814, 10 MG/KG | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| OG004 | MEDI7814, 20 MG/KG | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
|
|
| Secondary | Pharmacokinetic (PK) Parameters of MEDI7814 | Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed. | Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued. | Posted | Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106 |
|
|
| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 | Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued. | Posted | Day 1, 29, 57, 85, and 106 |
|
|
| 1 |
| 8 |
| 4 |
| 8 |
| EG001 | MEDI7814, 1 MG/KG | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. | 0 | 6 | 2 | 6 |
| EG002 | MEDI7814, 3 MG/KG | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. | 0 | 6 | 4 | 6 |
| EG003 | MEDI7814, 10 MG/KG | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. | 0 | 6 | 3 | 6 |
| EG004 | MEDI7814, 20 MG/KG | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. | 0 | 6 | 1 | 6 |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
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