Intravenous doses of GSK1995057 in healthy subjects

• Research type

  Research Study

• Full title

  A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of intravenously infused GSK1995057 in healthy subjects

• IRAS ID

  73444

• Contact name

  John Lambert

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-023836-18

• Research summary

  GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this first-time-in-human (FTIH) study is to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of intravenous GSK1995057 in healthy subjects. The study will be in two parts. Part A is a single-dose escalating design of 7 sequential cohorts of healthy subjects. Part B is a repeat-dose escalating design comprising 2 sequential cohorts of healthy subjects. Actual doses administered in Part B will be determined from emerging safety and PK data from Part A.

• REC name

  Scotland A REC

• REC reference

  11/IE/0005

• Date of REC Opinion

  28 Feb 2011

• REC opinion

  Further Information Favourable Opinion