A Study to Evaluate the Pharmacokinetics, Safety and Tolerability, Immunogenicity, and Pharmacodynamics of GSK2800528 in Healthy Subjects
Abstract
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).
Conditions: Psoriasis.
Primary outcome: Apparent systemic clearance (CL/F) of GSK2800528; Apparent systemic clearance (CL/F) of adalimumab; Adverse event (AE) and Serious Adverse event (SAE) reporting; Laboratory safety assessment for clinical chemistry parameters; Laboratory safety assessment for hematology parameters; Laboratory safety assessment for urinalysis parameters; Vital signs monitoring (blood pressure, heart rate, body temperature); Electrocardiogram (ECG) monitoring.
Enrollment: 45 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 45 participants or records.
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