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- Klinische proef NCT02290340
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 september 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
151
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Santiago, Chili
- Research Site
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Valdivia, Chili
- Research Site
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California
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Anaheim, California, Verenigde Staten
- Research Site
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Ontario, California, Verenigde Staten
- Research Site
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New York
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Syracuse, New York, Verenigde Staten
- Research Site
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Ohio
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Cleveland, Ohio, Verenigde Staten
- Research Site
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South Carolina
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Charleston, South Carolina, Verenigde Staten
- Research Site
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Utah
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Saint George, Utah, Verenigde Staten
- Research Site
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Wisconsin
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Marshfield, Wisconsin, Verenigde Staten
- Research Site
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Cape Town, Zuid-Afrika
- Research Site
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East London, Zuid-Afrika
- Research Site
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Johannesburg, Zuid-Afrika
- Research Site
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Pretoria, Zuid-Afrika
- Research Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 1 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Participants will receive placebo intramuscularly.
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Participants will receive placebo intramuscularly.
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 januari 2015
Primaire voltooiing (Werkelijk)
28 september 2016
Studie voltooiing (Werkelijk)
28 september 2016
Studieregistratiedata
Eerst ingediend
17 oktober 2014
Eerst ingediend dat voldeed aan de QC-criteria
10 november 2014
Eerst geplaatst (Schatting)
14 november 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 september 2018
Laatste update ingediend die voldeed aan QC-criteria
18 september 2018
Laatst geverifieerd
1 september 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D5290C00002
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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