A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants (MEDI8897 1b)
18. září 2018 aktualizováno: MedImmune LLC
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
151
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Santiago, Chile
- Research Site
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Valdivia, Chile
- Research Site
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Cape Town, Jižní Afrika
- Research Site
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East London, Jižní Afrika
- Research Site
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Johannesburg, Jižní Afrika
- Research Site
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Pretoria, Jižní Afrika
- Research Site
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California
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Anaheim, California, Spojené státy
- Research Site
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Ontario, California, Spojené státy
- Research Site
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New York
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Syracuse, New York, Spojené státy
- Research Site
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Ohio
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Cleveland, Ohio, Spojené státy
- Research Site
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South Carolina
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Charleston, South Carolina, Spojené státy
- Research Site
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Utah
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Saint George, Utah, Spojené státy
- Research Site
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Wisconsin
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Marshfield, Wisconsin, Spojené státy
- Research Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
Ne starší než 1 rok (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Key Inclusion Criteria:
- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
- Infants who are entering their first RSV season at the time of screening
Key Exclusion Criteria:
- Gestational age < 32 weeks 0 days and >34 weeks 6 days
- Meets AAP or other local criteria to receive commercial palivizumab
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
Participants will receive placebo intramuscularly.
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Participants will receive placebo intramuscularly.
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Experimentální: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
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Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
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Experimentální: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
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Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
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Experimentální: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
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Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Časové okno: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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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.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Časové okno: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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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.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
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Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Časové okno: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
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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.
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From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Maximum Observed Serum Concentration (Cmax) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The Cmax is the maximum observed serum concentration of MEDI8897.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
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Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
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Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Terminal Elimination Half Life (t1/2) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Extravascular Clearance (CL/F) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Extravascular Volume of Distribution (Vz/F) of MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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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.
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Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
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Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Časové okno: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
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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.
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Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
13. ledna 2015
Primární dokončení (Aktuální)
28. září 2016
Dokončení studie (Aktuální)
28. září 2016
Termíny zápisu do studia
První předloženo
17. října 2014
První předloženo, které splnilo kritéria kontroly kvality
10. listopadu 2014
První zveřejněno (Odhad)
14. listopadu 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. září 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. září 2018
Naposledy ověřeno
1. září 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- D5290C00002
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Respirační syncytiální virus
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Onze Lieve Vrouw HospitalUniversiteit Antwerpen; MSD Belgium BVBADokončenoRespirator-Gated Imaging TechnikyBelgie