Inhaled doses of GSK1995057 in healthy subjects

• Research type

  Research Study

• Full title

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

• IRAS ID

  56720

• Contact name

  John Lambert

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-019010-24

• 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 and pharmacokinetics of GSK1995057 in healthy subjects in addition to assessing its effect on lung inflammation following inhaled lipopolysaccharide (LPS) challenge. The study will be in three parts. Part 1a is a single-dose escalating design of 7 sequential cohorts of healthy subjects. Part 1b is a parallel group design comprising 3 groups of healthy subjects whilst Part 2 is a repeat-dose escalating design comprising 2 sequential cohorts of healthy subjects.Actual doses administered in Parts 1b and 2 will be determined from emerging safety and PK data from Part 1a.Parts 1a and 2 will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. Part 1b will be performed the Belfast City Hospital with overnight stays at Celerion (Belfast).

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  10/IEC06/4

• Date of REC Opinion

  29 Jun 2010

• REC opinion

  Favourable Opinion