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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2800528 Arm | Experimental | Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. |
|
| Placebo Arm | Placebo Comparator | Subjects will be assigned to treatments in accordance with the randomization schedule in Cohorts 1 to 3. Treatments will be randomized with placebo in a 3:1 ratio. The final randomization code will also pre-define the sentinel subjects to ensure that of the first two subjects in each cohort, one will receive GSK2800528 and the other will receive placebo. |
|
| Adalimumab Arm | Active Comparator | In Cohort 4, all subjects will receive adalimumab 40 mg (0.8 mL solution) as subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2800528, solution for injection | Drug | Drug will be administered at 3 different dose levels by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apparent systemic clearance (CL/F) of GSK2800528 | Up to Day 196 | |
| Apparent systemic clearance (CL/F) of adalimumab | Up to Day 140 | |
| Adverse event (AE) and Serious Adverse event (SAE) reporting | 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. | Up to Day 196 |
| Laboratory safety assessment for clinical chemistry parameters | 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 | Up to Day 196 |
| Laboratory safety assessment for hematology parameters | 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. | Up to Day 196 |
| Laboratory safety assessment for urinalysis parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of GSK2800528 and derived pharmacokinetic parameters other than CL/F | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 116987 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116987 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Placebo (0.9% w/v Sodium Chloride), solution for injection | Drug | Subcutaneous injection of. 0.8 mL solution will be administered |
|
| Adalimumab, solution for injection | Drug | Subcutaneous injection of 0.8 mL solution will be administered (40mg) |
|
Safety data for laboratory urinalysis parameters including specific gravity, pH, glucose, protein, blood and ketones by dipstick , and microscopic examination will be assessed
| Up to Day 196 |
| Vital signs monitoring (blood pressure, heart rate, body temperature) | Safety data for vital signs including blood pressure, heart rate, and body temperature will be measured | Up to Day 196 |
| Electrocardiogram (ECG) monitoring | Supine 12-lead ECG data will be monitored | Up to Day 196 |
| Up to Day 196 |
| Plasma concentrations of adalimumab and derived pharmacokinetic parameters other than CL/F | 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 | Up to Day 140 |
| Incidence, titers, and specificity of anti-GSK2800528 antibodies. | Up to Day 196 |
| Incidence, titers, and specificity of anti-adalimumab antibodies | Up to Day 140 |
| Neutralising activity for samples with confirmed anti-drug antibodies | Up to Day 196 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116987 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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