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NCT01035645: A18110040

First Time in Human Study of Intravenous Interleukin-18 Antibody

Completed Phase 1 Last updated 12 June 2017
What this trial tests

Phase 1 trial testing GSK1070806 in Inflammatory Bowel Diseases in 78 participants. Completed in 11 July 2012.

Timeline
5 January 2010
Primary endpoint
11 July 2012
11 July 2012

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment78
Start date5 January 2010
Primary completion11 July 2012
Estimated completion11 July 2012
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, male only, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

GSK1070806 is a humanised monoclonal antibody that blocks a protein present in the body called Interleukin-18. The main purpose of this study is to test GSK1070806 in healthy and obese male subjects with normal immune systems to find out how safe this drug is and how long the body takes to get rid of it. The study consists of 2 parts. Part 1 will consist of 6 groups of healthy male subjects and Part 2 will consist of 3 groups of obese male subjects. A total of 89 subjects is planned for this study. Subjects in each group will receive one dose of the study drug or placebo. Dosing in Part 2 will not start until dosing of the first 4 groups is completed in Part 1 and the preliminary safety and pharmacokinetic data from these 4 groups in Part 1 has been reviewed. Both parts will be conducted single-blind and with a placebo control. Within each group, allocation of subjects to placebo or active treatment (GSK1070806) will be randomised.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
    Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
  2. Role of inflammasomes in the pathogenesis of periodontal disease and therapeutics.
    Marchesan JT, Girnary MS, Moss K, Monaghan ET, et al · · 2020 · cited 96× · PMID 31850638 · DOI 10.1111/prd.12269
  3. IL-33 and IL-18 in Inflammatory Bowel Disease Etiology and Microbial Interactions.
    Williams MA, O'Callaghan A, Corr SC. · · 2019 · cited 73× · PMID 31139196 · DOI 10.3389/fimmu.2019.01091
  4. Targeting the IL-1 family members in skin inflammation.
    Jensen LE. · · 2010 · cited 62× · PMID 21157640
  5. Interleukin-18 Binding Protein in Immune Regulation and Autoimmune Diseases.
    Park SY, Hisham Y, Shin HM, Yeom SC, et al · · 2022 · cited 19× · PMID 35885055 · DOI 10.3390/biomedicines10071750
  6. Interleukin-18 Binding Protein (IL-18BP): A Long Journey From Discovery to Clinical Application.
    Kim S, Yu H, Azam T, Dinarello CA. · · 2024 · cited 4× · PMID 38455460 · DOI 10.4110/in.2024.24.e1

Verify or expand the search:

Other trials of GSK1070806

Trials testing the same drug.

Other recruiting trials for Inflammatory Bowel Diseases

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing