First-in-man study on a new treatment for asthma

• Research type

  Research Study

• Full title

  A First in Man Randomized Placebo-Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

• IRAS ID

  52285

• Contact name

  John Lambert

• Sponsor organisation

  NovImmune SA

• Eudract number

  2010-019757-18

• Research summary

  The study drug (a compound called NI-0701) is being developed for treating asthma. New treatments are needed because the currently available treatments are not always effective and/or safe. In this study, NI-0701 will be administered for the first time in humans. Safety, tolerability, plasma concentrations and the effects of NI-0701 will be investigated. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. In total up to 40 subjects are planned to be included in the study. Only healthy volunteers will be included in the study. Subjects will participate in up to 5 cohorts of 8 subjects each. In each cohort, six subjects will receive the active study drug (NI-0701) and two subjects will receive placebo. The study drug, in different doses per cohort, will be administered in the form of an intravenous infusion, which will be given over a maximum period of 2 hours. During the study subjects will undergo the following procedures: medical history and demographic data will be collected, physical examinations and different kinds of electrocardiograms (ECGs) will be performed, height and weight will be measured, vital signs (blood pressure, heart rate and body temperature measurements) will be taken, different kinds of urine and blood safety tests will be performed, blood samples for measurement of the concentrations of study drug and also for measurement of some of the effects of the study drug will be taken, the response will be assessed after injection of a very small volume of a skin irritant called histamine just underneath the forearm skin, any adverse events that subjects experience and other medication they take, will be recorded.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/8

• Date of REC Opinion

  26 May 2010

• REC opinion

  Further Information Favourable Opinion