A Randomised, Double-Blind (Sponsor Unblind), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single Ascending Doses of a Fully Humanized Anti-IL-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers
Description
GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being developed for the treatment of autoimmune indications. This study is intended to further explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol 18 subjects in total, with 9 subjects in each of the two cohorts.
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Publication Details
DOI
Publisher
Vivli
License
Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/
Subfield
Pharmacology
Field
Medicine
Domain
Health Sciences
Confidence Score
50%
Source
Scholar Data Model