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Studie av GSK3511294 i friska kinesiska deltagare

22 maj 2026 uppdaterad av: GlaxoSmithKline

En öppen endosstudie för att undersöka farmakokinetiken, säkerheten, tolerabiliteten och immunogeniciteten hos två dosnivåer av GSK3511294 administrerad subkutant hos friska kinesiska deltagare

Denna farmakokinetiska enkeldosstudie (PK) syftar till att undersöka farmakokinetik, säkerhet, tolerabilitet och immunogenicitet hos två dosnivåer av GSK3511294 administrerade subkutant hos friska kinesiska deltagare

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
      • Hangzhou, Kina, 310006
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Ja

Beskrivning

Inklusionskriterier:

  • Deltagare mellan 18 till 45 år.
  • Deltagare som är öppet friska enligt medicinsk utvärdering inklusive medicinsk historia, fysisk undersökning, laboratorietester, elektrokardiogram och vitala tecken.
  • Kroppsvikt större än eller lika med (>=)50,0 kg (kg) för män, >=45,0 kg för kvinnor och kroppsmassaindex (BMI) inom intervallet (19,0-26,0) kg/meter kvadrat (m^2) (inklusive).
  • Preventivmedelsanvändning av män och/eller kvinnor bör överensstämma med lokala bestämmelser om preventivmetoder för dem som deltar i kliniska studier.
  • Kan ge undertecknat informerat samtycke.

Exklusions kriterier:

  • Deltagaren är gravid, ammar eller en kvinna i fertil ålder
  • Historik eller förekomst av kardiovaskulära, respiratoriska, lever-, njur-, gastrointestinala, endokrina, hematologiska eller neurologiska störningar som avsevärt kan förändra absorption, metabolism eller eliminering av läkemedel
  • Deltagare med allergi/intolerans mot en monoklonal antikropp eller biologisk eller deltagare med tidigare kliniskt signifikanta multipla eller allvarliga allergiska reaktioner/intolerans
  • Aktuella bevis eller nyare historia av en infektionssjukdom
  • En positiv drog/alkoholscreening före studien eller en historia (eller misstänkt historia) av alkoholmissbruk eller drogmissbruk
  • Kliniskt signifikanta avvikelser
  • Deltagare med Coronavirus Disease-2019 (COVID-19)
  • Med tidigare/samtidig klinisk studieerfarenhet.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Depemokimab 100mg
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
Biologisk: Depemokimab
Depemokimab was administered.
Andra namn:
  • GSK3511294
Experimentell: Depemokimab 300mg
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
Biologisk: Depemokimab
Depemokimab was administered.
Andra namn:
  • GSK3511294

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Utredare

  • Studierektor: GSK Clinical Trials, GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 december 2021

Primärt slutförande (Faktisk)

23 december 2022

Avslutad studie (Faktisk)

23 december 2022

Studieregistreringsdatum

Först inskickad

22 november 2021

Först inskickad som uppfyllde QC-kriterierna

22 november 2021

Första postat (Faktisk)

1 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 208021

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

IPD för denna studie kommer att göras tillgänglig via webbplatsen för begäran om kliniska studier.

Tidsram för IPD-delning

IPD kommer att göras tillgänglig inom 6 månader efter publicering av resultaten av de primära endpoints, en viktig sekundär endpoints och säkerhetsdata för studien.

Kriterier för IPD Sharing Access

Tillgång ges efter att ett forskningsförslag har lämnats in och har fått godkännande från den oberoende granskningspanelen och efter att ett datadelningsavtal har ingåtts. Tillträde ges för en inledande period av 12 månader men en förlängning kan beviljas, när det är motiverat, med upp till ytterligare 12 månader.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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