Study to Investigate a New Drug in Healthy Subjects (SAD,MAD)

• 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 and intravenous GSK2862277 in healthy volunteers

• IRAS ID

  122264

• Contact name

  Annelize Koch

• Sponsor organisation

  GlaxoSmithKline Research and Development Limited

• Eudract number

  2012-002918-39

• ISRCTN Number

  xx

• Research summary

  GSK2862277 is being investigated for potential utility in prevention and treatment of acute lung injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS), in addition to other inflammatory respiratory diseases, by either inhalation (IH) or intravenous (IV) route.This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation or intravenous routes in healthy subjects.Approximately 56 evaluable subjects will be enrolled in the study.?½ Part 1 will target 18 evaluable subjects.?½ Part 2 will target 22 evaluable subjects?½ Part 3 will target enrolment of up to 16 evaluable subjects.Females of non-childbearing potential are permitted to enroll into this study in addition to male subjects.Cohorts may be expanded to further evaluate safety and PK findings at a given dose level if that cohort has not reached any of the dose escalation stopping criteria.If PK comparability criteria are not met, an additional cohort of 6 evaluable subjects will be enrolled in the study to more fully explore the dose-range and exposure-response relationship in Part 1.Safety such as vital signs, physical exams, laboratory safety tests and adverse events as well as concomitant medications will be monitored throughout the entire investigational period.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/0038

• Date of REC Opinion

  19 Feb 2013

• REC opinion

  Further Information Favourable Opinion