A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects
Status:
Completed
Trial end date:
2016-04-11
Target enrollment:
Participant gender:
Summary
GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being
developed for the treatment of inflammatory and fibrotic diseases. This first time in human
study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and
immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811, in
healthy subjects.
This study will be a randomised, double-blind (sponsor open), placebo-controlled, single
centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy
subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each
cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive
GSK2330811 and 2 subjects will receive placebo.
The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose and
the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the clinical
unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a s.c. dose of
GSK2330811 or placebo. Subjects will then remain as an in-patient until discharged on Day 8,
after assessments have been performed. The duration of the study, including screening, is
approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.