GSK3511294:n tutkimus terveillä kiinalaisilla osallistujilla
perjantai 22. toukokuuta 2026 päivittänyt: GlaxoSmithKline
Avoin, kerta-annostutkimus, jossa tutkittiin GSK3511294:n kahden annoksen farmakokinetiikkaa, turvallisuutta, siedettävyyttä ja immunogeenisyyttä ihon alle annettuna terveille kiinalaisille osallistujille
Tämän kerta-annoksen farmakokineettisen (PK) tutkimuksen tarkoituksena on tutkia kahden ihon alle annetun GSK3511294-annoksen PK:ta, turvallisuutta, siedettävyyttä ja immunogeenisyyttä terveille kiinalaisille osallistujille.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
20
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Hangzhou, Kiina, 310006
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 45 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Sisällyttämiskriteerit:
- Osallistuja on 18-45-vuotias.
- Osallistujat, jotka ovat selvästi terveitä lääketieteellisen arvioinnin mukaan, mukaan lukien sairaushistoria, lääkärintarkastus, laboratoriokokeet, EKG ja elintoiminnot.
- Ruumiinpaino suurempi tai yhtä suuri (>=)50,0 kg (kg) miehillä, >=45,0 kg naisilla ja painoindeksi (BMI) alueella (19,0-26,0) kg/neliömetri (m^2) (mukaan lukien).
- Miesten ja/tai naisten ehkäisyvälineiden tulee olla kliinisiin tutkimuksiin osallistuvien ehkäisymenetelmiä koskevien paikallisten määräysten mukaisia.
- Pystyy antamaan allekirjoitetun tietoon perustuvan suostumuksen.
Poissulkemiskriteerit:
- Osallistuja on raskaana, imettävä tai hedelmällisessä iässä oleva nainen
- Aiempi tai esiintynyt sydän- ja verisuoni-, hengitys-, maksa-, munuaisten, maha-suolikanavan, endokriinisiä, hematologisia tai neurologisia häiriöitä, jotka voivat merkittävästi muuttaa lääkkeiden imeytymistä, aineenvaihduntaa tai eliminaatiota
- Osallistujat, joilla on allergia/intoleranssi monoklonaaliselle vasta-aineelle tai biologiselle vasta-aineelle tai osallistujat, joilla on aiemmin ollut kliinisesti merkittäviä useita tai vakavia allergisia reaktioita/intoleranssia
- Nykyiset todisteet tai lähihistoria infektiosairaudesta
- Positiivinen tutkimusta edeltävä huume-/alkoholiseulonta tai historia (tai epäilty historia) alkoholin väärinkäytöstä tai päihteiden väärinkäytöstä
- Kliinisesti merkittävät poikkeavuudet
- Osallistujat, joilla on koronavirustauti-2019 (COVID-19)
- Aiemman/samanaikaisen kliinisen tutkimuksen kokemuksella.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Depemokimab 100mg
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
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Depemokimab was administered.
Muut nimet:
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Kokeellinen: Depemokimab 300mg
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
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Depemokimab was administered.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab
Aikaikkuna: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183
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Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity).
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183
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AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab
Aikaikkuna: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183
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Blood samples were collected from participants at indicated time points and analyzed for AUC(0-T).
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183
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AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29
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Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 4).
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 4 post-dose correlates to Day 1 plus 28 days, that is, Day 29.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29
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AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85
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Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 12).
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, that is, Day 85.
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Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85
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AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 26).
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for percentage of AUC(0-Infinity) obtained by extrapolation.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Maximum Observed Plasma Concentration (Cmax) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Cmax.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Time of Occurrence of Cmax (Tmax) Of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Tmax.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Tmax was determined directly from the plasma concentration-time data.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Time To Last Quantifiable Concentration (Tlast) of Depemokimab
Aikaikkuna: Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Tlast.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Apparent Clearance (CL/F) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Apparent Clearance.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Apparent Volume of Distribution (Vz/F) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for apparent volume of distribution.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Terminal Elimination Rate Constant (Lambda Z) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Terminal elimination rate constant.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Terminal Phase Half-Life (T1/2) of Depemokimab
Aikaikkuna: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Blood samples were collected from participants at indicated time points and analyzed for Terminal phase half-life.
Pharmacokinetic parameters were calculated by standard non compartmental analysis.
As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
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Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)
Aikaikkuna: From the start of the study intervention (Day 1) up to Day 211 (End of follow-up)
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is considered or defined as an important medical event.
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From the start of the study intervention (Day 1) up to Day 211 (End of follow-up)
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Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential that is, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Change From Baseline in Hematology Parameter: Hemoglobin
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Blood samples were collected for the assessment of change from baseline in hematology parameters including Hemoglobin.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Hematology Parameter: Hematocrit
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Blood samples were collected for the assessment of change from baseline in hematology parameters including Hematocrit.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Blood samples were collected for the assessment of change from baseline in hematology parameters including mean corpuscular volume.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Blood samples were collected for the assessment of change from baseline in hematology parameters including mean Corpuscular Hemoglobin.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Hematology Parameter: Reticulocytes
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Blood samples were collected for the assessment of change from baseline in hematology parameters including Reticulocytes.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Change From Baseline In Hematology Parameter: Erythrocytes
Aikaikkuna: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Change from baseline in hematology parameter including Erythrocytes.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Aikaikkuna: Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples was collected for the assessment of clinical chemistry parameters including Sodium, potassium, calcium, glucose, and urea.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Aikaikkuna: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples was collected for the assessment of clinical chemistry parameters including direct bilirubin, bilirubin, and creatinine[MB10.1].
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
Aikaikkuna: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples was collected for the assessment of clinical chemistry parameters including AST, ALT, ALP, and GGT.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Aikaikkuna: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples was collected for the assessment of clinical chemistry parameters including Albumin.
and Total Protein.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Absolute Values of Complement C3 And C4 at Each Timepoint
Aikaikkuna: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4).
Baseline was defined as latest pre-dose assessment with a non-missing value.
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Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Ratio to Baseline at Each Timepoint of Complement C3 And C4
Aikaikkuna: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4).
Baseline was defined as latest pre-dose assessment with a non-missing value.
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Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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Change From Baseline in Systolic and Diastolic Blood Pressure
Aikaikkuna: Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Systolic blood pressure (sBP) is a measure of blood pressure while the heart is beating.
Diastolic blood pressure (dBP) is a measure of blood pressure while the heart is relaxed.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Body Temperature
Aikaikkuna: Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Day 2, 3, 5, Week 1, 2, 4, 8, 12, 18, 24 and 26
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Body temperature was measured in participants in resting state.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Day 2, 3, 5, Week 1, 2, 4, 8, 12, 18, 24 and 26
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Change From Baseline in Pulse Rate
Aikaikkuna: Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26
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The vital signs followed in this analysis was pulse rate, expressed as beats per minute (bpm).
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26
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Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
Aikaikkuna: Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26
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12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR interval, QRS duration, QT interval and corrected QT using Fridericia's Formula (QTc[MB13.1]F)
intervals.
ECG measurements were performed in triplicate.
When multiple ECGs were performed at the same planned timepoint, the aggregate [MB14.1]value of each parameter was used.
Baseline was defined as latest pre-dose assessment with a non-missing value.
Change from Baseline was defined as post-dose visit value minus Baseline value.
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Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26
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Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Aikaikkuna: Day 1 (Pre-dose), Week 4, Week 12, and Week 26
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Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method.
Data is reported by visit.
The results were categorized as negative and positive.
A participant is considered positive if they have at least one positive post-Baseline ADA result.
Number of participants with positive ADAs against depemokimab was reported in this outcome measure.
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Day 1 (Pre-dose), Week 4, Week 12, and Week 26
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Titres of Binding ADA's to Depemokimab
Aikaikkuna: Up to Week 26
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Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method.
Data is reported by visit.
Titer was only measured when a positive result was found.
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Up to Week 26
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: GSK Clinical Trials, GlaxoSmithKline
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 10. joulukuuta 2021
Ensisijainen valmistuminen (Todellinen)
Perjantai 23. joulukuuta 2022
Opintojen valmistuminen (Todellinen)
Perjantai 23. joulukuuta 2022
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 22. marraskuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 22. marraskuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 1. joulukuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 26. toukokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 22. toukokuuta 2026
Viimeksi vahvistettu
Perjantai 1. toukokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 208021
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Tämän tutkimuksen IPD on saatavilla Clinical Study Data Request -sivuston kautta.
IPD-jaon aikakehys
IPD on saatavilla 6 kuukauden kuluessa tutkimuksen primaaristen päätepisteiden tulosten, tärkeimpien toissijaisten päätepisteiden ja turvallisuustietojen julkaisemisesta.
IPD-jaon käyttöoikeuskriteerit
Käyttöoikeus myönnetään sen jälkeen, kun tutkimusehdotus on lähetetty ja saatu riippumattomalta arviointipaneelilta hyväksynnän ja tiedonjakosopimuksen solmimisen jälkeen.
Käyttöoikeus tarjotaan aluksi 12 kuukauden ajaksi, mutta sitä voidaan perustellusti pidentää enintään 12 kuukaudeksi.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .