Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants

Pediatric Infectious Disease Journal

Volumn 37, Issue 9, 2018, Pages 886-892

  Domachowske, Joseph B ^a   Khan, Anis A ^b   Esser, Mark T ^b   Jensen, Kathryn ^b   Takas, Therese ^b   Villafana, Tonya ^b   Dubovsky, Filip ^b   Griffin, M Pamela ^b  

^a State University of New York Upstate Medical University: College of Medicine   (United States)

^b MEDIMMUNE   (United States)

Author keywords

Infants; Lower respiratory tract infections; MEDI8897; Preterm infants; Respiratory syncytial virus

Indexed keywords

DRUG ANTIBODY; NEUTRALIZING ANTIBODY; NIRSEVIMAB; PLACEBO; ANTIVIRUS AGENT; F PROTEIN, HUMAN RESPIRATORY SYNCYTIAL VIRUS; MONOCLONAL ANTIBODY; VIRUS ANTIBODY; VIRUS FUSION PROTEIN;

ANEMIA; ANTIBODY RESPONSE; AREA UNDER THE CURVE; ARTICLE; BRONCHIOLITIS; CANDIDIASIS; CHILE; CLINICAL OUTCOME; COHORT ANALYSIS; CONTROLLED STUDY; COUGHING; DIAPER DERMATITIS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; EC90; ECZEMA; ELIMINATION HALF-LIFE; FEBRILE CONVULSION; FEMALE; FEVER; FOLLOW UP; GASTROENTERITIS; GESTATIONAL AGE; HUMAN; HUMAN METAPNEUMOVIRUS INFECTION; IC50; INFANT; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NOSE OBSTRUCTION; OTITIS MEDIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLASMA HALF LIFE; PREMATURITY; PRIORITY JOURNAL; PROTECTION; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RHINORRHEA; SINGLE DRUG DOSE; SOUTH AFRICA; THRUSH; TIME TO MAXIMUM PLASMA CONCENTRATION; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; VOLUME OF DISTRIBUTION; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECT; GENETICS; HALF LIFE TIME; HUMAN RESPIRATORY SYNCYTIAL VIRUS; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; ISOLATION AND PURIFICATION;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; ANTIVIRAL AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GESTATIONAL AGE; HALF-LIFE; HUMANS; INFANT; INFANT, PREMATURE; INJECTIONS, INTRAMUSCULAR; MALE; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RESPIRATORY SYNCYTIAL VIRUS, HUMAN; VIRAL FUSION PROTEINS;

EID: 85050480362     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0000000000001916     Document Type: Article

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