GSK Investigational Site
London, NW10 7EW, United Kingdom
NCT Number: NCT01899755
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12 subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a group of 9 subjects, all on active treatment (adalimumab).
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
London, NW10 7EW, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug will be administered at 3 different dose levels by subcutaneous injection.
Subcutaneous injection of. 0.8 mL solution will be administered
Subcutaneous injection of 0.8 mL solution will be administered (40mg)
Time frame: Up to Day 196
Time frame: Up to Day 140
Time frame: Up to Day 196
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function.
Time frame: Up to Day 196
Safety data for laboratory clinical chemistry parameters including albumin, creatinine, glucose, sodium, potassium, chloride, calcium, total protein, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatise, total and direct bilirubin, and uric acid will be assessed
Time frame: Up to Day 196
Safety data for laboratory hematology parameters including platelet count, red blood cell (RBC) count, absolute white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC), mean corpuscular haemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, and basophils will be assessed.
Time frame: Up to Day 196
Safety data for laboratory urinalysis parameters including specific gravity, pH, glucose, protein, blood and ketones by dipstick , and microscopic examination will be assessed
Time frame: Up to Day 196
Safety data for vital signs including blood pressure, heart rate, and body temperature will be measured
Time frame: Up to Day 196
Supine 12-lead ECG data will be monitored
Time frame: Up to Day 196
Blood samples for PK analysis of GSK2800528 will be collected to assess plasma concentration and derived PK parameters including maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration time curve [AUC(0-t) and AUC(0-infinity)], and apparent terminal phase half-life (t1/2)
Time frame: Up to Day 140
Blood samples for PK analysis of adalimumab will be collected to assess plasma concentration and derived PK parameters including Cmax, tmax, AUC(0-t) and AUC(0-infinity), and t1/2
Time frame: Up to Day 196
Time frame: Up to Day 140
Time frame: Up to Day 196
GlaxoSmithKline
Industry
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability, Immunogenicity, and Pharmacodynamics of GSK2800528 in Healthy Subjects.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04728165
Psoriasis, Skin Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01778569
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05295979
Psoriasis, Skin Diseases
Hong Kong
View Trial DetailsNCT07712731
Psoriasis, Skin Diseases
Baotou, China
View Trial Details