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Studie GSK3511294 u zdravých čínských účastníků

22. května 2026 aktualizováno: GlaxoSmithKline

Otevřená studie s jednou dávkou ke zkoumání farmakokinetiky, bezpečnosti, snášenlivosti a imunogenicity dvou úrovní dávek GSK3511294 podaných subkutánně u zdravých čínských účastníků

Tato farmakokinetická (PK) studie s jednou dávkou má za cíl prozkoumat farmakokinetiku, bezpečnost, snášenlivost a imunogenicitu dvou dávek GSK3511294 podaných subkutánně zdravým čínským účastníkům

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

20

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

  • Čína
      • Hangzhou, Čína, 310006
        • GSK Investigational Site

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

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Popis

Kritéria pro zařazení:

  • Účastník ve věku 18 až 45 let.
  • Účastníci, kteří jsou zjevně zdraví podle lékařského hodnocení včetně anamnézy, fyzikálního vyšetření, laboratorních testů, elektrokardiogramů a vitálních funkcí.
  • Tělesná hmotnost větší nebo rovna (>=)50,0 kilogramů (kg) u mužů, >=45,0 kg u žen a index tělesné hmotnosti (BMI) v rozmezí (19,0-26,0) kg/metr čtvereční (m^2) (včetně).
  • Používání antikoncepce muži a/nebo ženami by mělo být v souladu s místními předpisy týkajícími se metod antikoncepce pro účastníky klinických studií.
  • Schopný dát podepsaný informovaný souhlas.

Kritéria vyloučení:

  • Účastnice je těhotná, kojící nebo žena ve fertilním věku
  • Anamnéza nebo přítomnost kardiovaskulárních, respiračních, jaterních, ledvinových, gastrointestinálních, endokrinních, hematologických nebo neurologických poruch schopných významně změnit absorpci, metabolismus nebo eliminaci léků
  • Účastníci s alergií/nesnášenlivostí na monoklonální protilátku nebo biologickou látku nebo účastníci s předchozí anamnézou klinicky významných mnohočetných nebo závažných alergických reakcí/nesnášenlivosti
  • Současné důkazy nebo nedávná historie infekčního onemocnění
  • Pozitivní screening drog/alkoholu před studií nebo anamnéza (nebo podezřelá historie) nadměrného užívání alkoholu nebo zneužívání látek
  • Klinicky významné abnormality
  • Účastníci s onemocněním Coronavirus-2019 (COVID-19)
  • S předchozí/souběžnou zkušeností z klinické studie.

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: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Depemokimab 100mg
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
Biologický: Depemokimab
Depemokimab was administered.
Ostatní jména:
  • GSK3511294
Experimentální: Depemokimab 300mg
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
Biologický: Depemokimab
Depemokimab was administered.
Ostatní jména:
  • GSK3511294

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab
Časové okno: 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
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.
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
AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab
Časové okno: 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
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.
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
AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab
Časové okno: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29
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.
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29
AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab
Časové okno: Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85
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.
Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85
AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab
Časové okno: 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
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.
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
Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab
Časové okno: 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
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.
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
Maximum Observed Plasma Concentration (Cmax) of Depemokimab
Časové okno: 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
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.
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
Time of Occurrence of Cmax (Tmax) Of Depemokimab
Časové okno: 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
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.
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
Time To Last Quantifiable Concentration (Tlast) of Depemokimab
Časové okno: 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
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.
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
Apparent Clearance (CL/F) of Depemokimab
Časové okno: 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
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.
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
Apparent Volume of Distribution (Vz/F) of Depemokimab
Časové okno: 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
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.
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
Terminal Elimination Rate Constant (Lambda Z) of Depemokimab
Časové okno: 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
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.
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
Terminal Phase Half-Life (T1/2) of Depemokimab
Časové okno: 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
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.
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)
Časové okno: From the start of the study intervention (Day 1) up to Day 211 (End of follow-up)
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.
From the start of the study intervention (Day 1) up to Day 211 (End of follow-up)
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
Change From Baseline in Hematology Parameter: Hemoglobin
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
Change From Baseline in Hematology Parameter: Hematocrit
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26
Change From Baseline in Hematology Parameter: Reticulocytes
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
Change From Baseline In Hematology Parameter: Erythrocytes
Časové okno: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
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.
Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Časové okno: Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Časové okno: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
Časové okno: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Časové okno: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
Absolute Values of Complement C3 And C4 at Each Timepoint
Časové okno: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Časové okno: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
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.
Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26
Change From Baseline in Systolic and Diastolic Blood Pressure
Časové okno: 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
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.
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
Change From Baseline in Body Temperature
Časové okno: 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
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.
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
Change From Baseline in Pulse Rate
Časové okno: 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
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.
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
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
Časové okno: 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
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.
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
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Časové okno: Day 1 (Pre-dose), Week 4, Week 12, and Week 26
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.
Day 1 (Pre-dose), Week 4, Week 12, and Week 26
Titres of Binding ADA's to Depemokimab
Časové okno: Up to Week 26
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.
Up to Week 26

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Vyšetřovatelé

  • Ředitel studie: GSK Clinical Trials, GlaxoSmithKline

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)

10. prosince 2021

Primární dokončení (Aktuální)

23. prosince 2022

Dokončení studie (Aktuální)

23. prosince 2022

Termíny zápisu do studia

První předloženo

22. listopadu 2021

První předloženo, které splnilo kritéria kontroly kvality

22. listopadu 2021

První zveřejněno (Aktuální)

1. prosince 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 208021

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

IPD pro tuto studii bude zpřístupněna prostřednictvím stránky žádosti o data klinické studie.

Časový rámec sdílení IPD

IPD bude k dispozici do 6 měsíců od zveřejnění výsledků primárních cílů, klíčových sekundárních cílů a údajů o bezpečnosti studie.

Kritéria přístupu pro sdílení IPD

Přístup je poskytován po předložení návrhu výzkumu a obdržení souhlasu nezávislého kontrolního panelu a poté, co je uzavřena dohoda o sdílení dat. Přístup je poskytován na počáteční období 12 měsíců, ale v odůvodněných případech lze povolit prodloužení až o dalších 12 měsíců.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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