First-in-human study on a new drug for Alzheimer's disease

• Research type

  Research Study

• Full title

  A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study, to assess safety, tolerability, pharmacokinetics and pharmacodynamics of CHN438 in healthy subjects

• IRAS ID

  104731

• Contact name

  John Lambert

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2011-005967-26

• Research summary

  The study drug does not yet have a name and is only known by the number CHN438. It is hoped that the study drug will be useful as a treatment for Alzheimer??s disease. So far it has only been tested in animals, and it is not yet licensed. This is a first-time-in-human (FTIH) study which means that this is the first time that the study drug will be given to humans. The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals. Also, the effect of the drug on protein levels in the cerebrospinaflud (CSFflud that circulates around the brain and spinal cord) will be assessed. The study will also try to understand why different people respond differently to the same drug through DNA testing. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. The study is divided into Part 1, Part 2 and Part 3. Separate groups of participants will be included in each part of the study.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0177

• Date of REC Opinion

  18 Jul 2012

• REC opinion

  Further Information Favourable Opinion