En undersøgelse til at sammenligne farmakokinetikken (PK) af Depemokimab, når det leveres med en sikkerhedssprøjteanordning (SSD) eller en autoinjektor hos raske voksne deltagere
20. maj 2026 opdateret af: GlaxoSmithKline
En åben-label, randomiseret, enkeltdosis, multicenter, parallel-gruppe undersøgelse til sammenligning af farmakokinetikken af subkutan depemokimab, når det leveres med en sikkerhedssprøjteanordning eller en autoinjektor hos raske voksne deltagere
Denne undersøgelse vil sammenligne farmakokinetikken, sikkerheden, tolerabiliteten og immunogeniciteten af Depemokimab administreret via en SSD eller autoinjektor hos raske deltagere.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Orlando, Florida, Forenede Stater, 32806
- GSK Investigational Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89113
- GSK Investigational Site
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Texas
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Austin, Texas, Forenede Stater, 78744
- GSK Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Deltagere, der er åbenlyst raske som bestemt af medicinsk evaluering, herunder sygehistorie, fysisk undersøgelse, kliniske laboratorietests, målinger af vitale tegn og 12-aflednings elektrokardiogramresultater.
- Kropsvægt større end eller lig med (>=) 50 kilogram (kg) (110 pund-masse/Ibs) og kropsmasseindeks inden for intervallet 19 til 30 kg pr. kvadratmeter (inklusive).
- Kvinder, der har potentiale til at blive gravide, skal bruge en form for højeffektiv prævention.
- I stand til at give underskrevet informeret samtykke.
Ekskluderingskriterier:
- Anamnese eller tilstedeværelse af eller aktuelle kardiovaskulære, respiratoriske, lever-, nyre-, gastrointestinale, endokrine, hæmatologiske eller neurologiske lidelser, der er i stand til væsentligt at ændre absorptionen, metabolismen eller elimineringen af lægemidler, hvilket udgør en risiko ved at tage undersøgelsesinterventionen eller interferere med fortolkning af data.
- Deltagere med allergi/intolerance over for et monoklonalt antistof eller biologisk eller deltagere med en tidligere historie med klinisk signifikant multipel eller svær lægemiddelallergi/intolerance.
- Aktuelle beviser eller nyere historie om en infektionssygdom.
- En positiv lægemiddel-/alkoholscreening før undersøgelsen eller en historie (eller formodet historie) med alkoholmisbrug eller stofmisbrug
- Klinisk signifikante abnormiteter.
- Positiv test for alvorligt akut respiratorisk syndrom coronavirus (SARS-CoV-2) ved screening.
- Nylig tidligere eller samtidig klinisk undersøgelseserfaring.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Depemokimab via SSD
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
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Depemokimab was administered via SSD or autoinjector.
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Eksperimentel: Depemokimab via autoinjector
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
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Depemokimab was administered via SSD or autoinjector.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Terminal Elimination Rate Constant (Lambda z) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Terminal Elimination Half-Life (T1/2) Following Administration of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Time of Last Measurable Plasma Concentrations (Tlast) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Percentage of AUC (0-Inf) Due to Extrapolation From the Time of the Last Observed Concentration (Tlast) to Infinity (%AUCex) of Depemokimab
Tidsramme: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Blood samples were collected at indicated time points for PK analysis of depemokimab.
PK analysis was conducted using standard non-compartmental methods.
The percentage of AUC (0-inf) obtained by extrapolation (%AUCex) was calculated as: (AUC[0-inf] - AUC[0-t]) /AUC(0-inf)*100.
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Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
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Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Tidsramme: Baseline (Day 1), Weeks 4, 8, 12 and 26
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Blood samples were collected and analyzed for the presence of anti- depemokimab antibodies using a validated immunoassay.
The assay involved screening, confirmation and titration steps.
If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay.
Samples that confirmed positive in the confirmation assay were reported as 'positive'.
Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Baseline (Day 1), Weeks 4, 8, 12 and 26
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Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Tidsramme: Baseline (Day 1), Weeks 4, 8, 12 and 26
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Blood samples were collected for determination of positive neutralizing antibodies.
A neutralizing antibody assay was performed.
Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit.
A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result.
Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Baseline (Day 1), Weeks 4, 8, 12 and 26
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: GSK Clinical Trials, GlaxoSmithKline
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. december 2022
Primær færdiggørelse (Faktiske)
23. oktober 2023
Studieafslutning (Faktiske)
23. oktober 2023
Datoer for studieregistrering
Først indsendt
27. oktober 2022
Først indsendt, der opfyldte QC-kriterier
27. oktober 2022
Først opslået (Faktiske)
1. november 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 214099
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalificerede forskere kan anmode om adgang til anonymiserede data på individuelt patientniveau (IPD) og relaterede undersøgelsesdokumenter fra de kvalificerede undersøgelser via datadelingsportalen.
Detaljer om GSK's datadelingskriterier kan findes på: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD-delingstidsramme
Anonymiseret IPD vil blive gjort tilgængelig inden for 6 måneder efter offentliggørelsen af primære, sekundære nøgle- og sikkerhedsresultater for undersøgelser af produkt med godkendte indikationer eller afsluttede aktiv(er) på tværs af alle indikationer.
IPD-delingsadgangskriterier
Anonymiseret IPD deles med forskere, hvis forslag er godkendt af et uafhængigt reviewpanel og efter en datadelingsaftale er på plads.
Adgangen gives i en indledende periode på 12 måneder, men en forlængelse kan gives, når det er berettiget, i op til 6 måneder.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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