First Time in Human Study of Intravenous Interleukin-18 Antibody (A18110040)
|ClinicalTrials.gov Identifier: NCT01035645|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases||Drug: GSK1070806||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||January 5, 2010|
|Actual Primary Completion Date :||July 11, 2012|
|Actual Study Completion Date :||July 11, 2012|
Experimental: GSK1070806 or placebo
This is a single dose escalating study. On enrolment into the study, each subject will be assigned to a group. These groups will be aligned to specific dose levels of GSK1070806. All subjects will be randomised to receive either a single intravenously administered dose of GSK1070806 or matching placebo (saline). The randomisation is generated by GSK prior to study start.
The study drug, GSK1070806, is a humanised monoclonal antibody. Antibodies are proteins that are made by white blood cells during an immune reaction. They circulate in the blood and attach to foreign proteins called antigens in order to destroy or neutralise them.
Humanised monoclonal antibodies are a type of protein that is genetically engineered to resemble a human protein (humanised). GSK1070806 is designed to block a specific protein that exists in the body called Interleukin-18. Interleukin-18 works within the immune system, i.e. the body's defence system, which helps protect it from disease, bacteria and viruses. Interleukin-18 activates the immune system to fight infections and may also occasionally cause inflammation.
- Adverse events, vital signs, cardiac and ECG parameters and clinical laboratory safety assessments. [ Time Frame: From screening upto 56 days for Part 1 subjects in groups 1 and 2. Upto 96 days for group 3 in Part 1 and 126 days for group 4 in Part 1. Upto 56 days for all Part 2 subjects. ]
- Plasma concentrations of GSK1070806 and derived pharmacokinetic parameters thereof. [ Time Frame: From dosing upto 56 days for subjects in groups 1 and 2, 152 days for group 3, 213 days for group 4, 274 days for group 8 and upto 300 days in group 9 in Part 1. Upto 152 days for group 5, 213 days for group 6 and 274 days for group 7 subjects in Part 2. ]
- Serum levels of Interleukin-18 (IL-18). [ Time Frame: From dosing upto 56 days for subjects in groups 1 and 2, 243 days for group 3, 213 days for group 4, 230 days for group 8 and upto 240 days in group 9 in Part 1. Upto 243 days for group 5, 213 days for group 6 and 230 days for group 7 subjects in Part 2. ]
- Endpoints of immune function and derived pharmacodynamic parameters thereof. [ Time Frame: From dosing upto 56 days for subjects in groups 1 and 2, 152 days for groups 3, 8 and 9 and 126 days for group 4 in Part 1. Upto 56 days for all Part 2 subjects. ]
- Serum levels of anti-GSK1070806 binding antibodies. [ Time Frame: From dosing upto 56 days for subjects in groups 1 and 2, 243 days for group 3, 213 days for group 4, 274 days for group 8 and 300 days for group 9 in Part 1. Upto 243 days for group 5, 213 days for group 6 and 274 days for group 7 in Part 2. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035645
|GSK Investigational Site|
|Cambridge, United Kingdom, CB2 2GG|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|