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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI8897 300 milligram (mg) Intravenous (IV) | Experimental | Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
|
| MEDI8897 1000 mg IV | Experimental | Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
|
| MEDI8897 3000 mg IV | Experimental | Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
|
| MEDI8897 100 mg Intramuscular (IM) | Experimental | Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
|
| MEDI8897 300 mg IM | Experimental | Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI8897 Intravenous | Drug | Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
|
| 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 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. | From start of study drug administration up to Day 391 (Day 361 +/- 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Pamela Griffin, MD | MedImmune LLC | Study Director |
| Martin Kankam, MD, PhD, MPH | Study Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27956428 | Derived | Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar. |
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There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo on Day 1. |
| FG001 | MEDI8897 300 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Comparator |
Participants received placebo on Day 1. |
|
| Placebo | Drug | Participants received placebo on Day 1. |
|
| MEDI8897 Intravenous | Drug | Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
|
| MEDI8897 Intravenous | Drug | Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
|
| MEDI8897 Intramuscular | Drug | Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
|
| MEDI8897 Intramuscular | Drug | Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
|
| 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). | 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 |
| 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). | 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 |
| 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). | 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) 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). | 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 |
| 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). | 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 |
| Number of Participants With Positive Anti-Drug Antibody (ADA) | Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose. | Predose and Day 15, 31, 91, 181, 271 and 361 |
| FG002 | MEDI8897 1000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
| FG003 | MEDI8897 3000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
| FG004 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| FG005 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The As-treated Population included participants who receive any study investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo on Day 1. |
| BG001 | MEDI8897 300 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
| BG002 | MEDI8897 1000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
| BG003 | MEDI8897 3000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
| BG004 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| BG005 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| BG006 | 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 | Years |
| |||||||||||||||
| Sex: Female, Male | 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 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. | The As-treated population included participants who receive any study investigational product. | Posted | Number | participants | From start of study drug administration up to Day 391 (Day 361 +/- 30 days) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | Day | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/ml) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | Day*microgram per milliliter | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | Day | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | ml per day | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure. | Posted | Mean | Standard Deviation | milliliter (ml) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | The As-treated Population included participants who receive any study investigational product. | Posted | Number | participants | Predose and Day 15, 31, 91, 181, 271 and 361 |
|
From Screening to Postdose Follow-up (up to 391 Days)
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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 on Day 1. | 0 | 34 | 21 | 34 | ||
| EG001 | MEDI8897 300 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | 0 | 6 | 3 | 6 | ||
| EG002 | MEDI8897 1000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | 0 | 6 | 3 | 6 | ||
| EG003 | MEDI8897 3000 Milligram (mg) Intravenous (IV) | Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | 0 | 6 | 5 | 6 | ||
| EG004 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | 0 | 6 | 4 | 6 | ||
| EG005 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. | 2 | 78 | 48 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharospasm | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Salivary gland pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Physical examination parameters of participants were not evaluated.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Pamela Griffin, MD, Senior Director | MedImmune, LLC | 301-398-0000 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| TESAEs |
|
| OG003 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) |
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
|
|
| MEDI8897 100 Milligram (mg) Intramuscular (IM) |
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
|
|
| MEDI8897 3000 Milligram (mg) Intravenous (IV) |
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
| OG003 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
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Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
| OG003 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
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|
Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
| OG003 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
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|
| OG003 | MEDI8897 100 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG004 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
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|
| OG004 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) |
Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| OG005 | MEDI8897 300 Milligram (mg) Intramuscular (IM) | Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
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