(HMR) FIH study to evaluate safety, tolerability, PK and PD of NOX-H94

• Research type

  Research Study

• Full title

  First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics of NOX-H94.

• IRAS ID

  81788

• Contact name

  J Brian Sanderson

• Eudract number

  2011-000705-46

• Research summary

  This is the first clinical study with study drug, NOX-H94. The purpose of the study is to identify a safe and efficacious treatment programme for the clinical development of NOX-H94 in patients with anaemia of chronic disease. The primary objective is to determine how safe and well tolerated the study drug is a single and higher doses in healthy subjects. Secondary objectives are to look at the way the body absorbs and eliminates the study drug along with looking at how the study drugs interacts with the body in healthy subjects and patient with anaemia (lowering of haemoglobin in the blood.

• REC name

  HSC REC A

• REC reference

  11/NI/0032

• Date of REC Opinion

  1 Apr 2011

• REC opinion

  Favourable Opinion