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First Time in Human Study of Intravenous Interleukin-18 Antibody — A18110040  

Inflammatory Bowel Diseases Clinical Trial

Official title:
A Single-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Intravenously Infused GSK1070806 in Healthy and Obese Subjects.

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01035645
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date January 5, 2010
Completion date July 11, 2012
View Details
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