First-In-Man study to assess doses of NI-0501

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, SINGLE CENTRE, PHASE I STUDY OF ESCALATING SINGLE INTRAVENOUS DOSES OF NI-0501 IN HEALTHY VOLUNTEERS.

• IRAS ID

  84970

• Sponsor organisation

  NovImmune SA

• Eudract number

  2011-003061-15

• ISRCTN Number

  n/a

• Research summary

  This study is being carried out to investigate a compound called NI-0501, which is being developed by the Sponsoring Company (NovImmune S.A.) and intended to be used as a treatment for a disease called Hemophagocytosis Lymphohistiocytosis (HLH) causing overwhelming inflammation with serious organ damages. This study will be the first time NI-0501 is administered 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 in a healthy volunteer population. The study will also investigate how the study drug is taken up, metabolised and distributed through the body, and how the immune system responds to the study drug. A total of up to 20 volunteers will participate in this study. The study consists of a screening visit, one admission day in the Phase I unit, one day of treatment and eight follow-up visits. The total study duration for each participant will be of approximately 11 weeks.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/1157

• Date of REC Opinion

  2 Aug 2011

• REC opinion

  Favourable Opinion