Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01899755 | A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects. | PHASE1 | COMPLETED | 45 | — | — | Jul 10, 2013 | Apr 3, 2014 | May 11, 2017 | 1 | United Kingdom |
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.
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
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.
Safety data for laboratory urinalysis parameters including specific gravity, pH, glucose, protein, blood and ketones by dipstick , and microscopic examination will be assessed
Safety data for vital signs including blood pressure, heart rate, and body temperature will be measured
Supine 12-lead ECG data will be monitored
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| GSK2800528, solution for injection | DRUG | Drug will be administered at 3 different dose levels by subcutaneous injection. |
| 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) |
Inclusion Criteria: * ALT, alkaline phosphatase and bilirubin \<= 1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Average bazett's corrected QT interval (QTcB) \< 450 msec, or QTcB \< 480 msec in subjects with ...