PK, Safety and Tolerability Study in Healthy Males

• Research type

  Research Study

• Full title

  A Single-center, Double-blind, Randomised, Single-Dose,Parallel Group Study Comparing the Pharmacokinetics, Safety, and Tolerability Following 5 mg/kg IV Infusion 1422015 and Remicade® in Healthy Male Volunteers

• IRAS ID

  100668

• Contact name

  John Lambert

• Sponsor organisation

  Fourteen22, Inc.

• Eudract number

  2012-000288-25

• Clinicaltrials.gov Identifier

  1

• Research summary

  The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow, London. The study drug, only known by the number 1422015, is similar to a product that is already marketed as Remicade© (comparator drug). Both products contain an active substance called infliximab. It is hoped that the study drug will be useful as a treatment for autoimmune and inflammatory disorders, and cancer. The main purpose of the study is to investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. The study will also investigate how safe the study drug is and how well it is tolerated after dosing. A further aim is to see if and to what extent the study drug stimulates the immune system. This study will recruit healthy, non smoking Caucasian males between the ages of 18 and 45 years. A total of up to 84 participants will take part in the study. The study is divided into two dose groups. In the first group 40 participants will receive 1422015 5 mg/kg and in the second group, 40 participants will receive Remicade© 5 mg/kg. Participants will either receive the 1422015 or Remicade©. Participants in the dosing groups will be matched for age and weight. Participants will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate, respiratory 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 concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded.

• REC name

  Wales REC 2

• REC reference

  12/WA/0048

• Date of REC Opinion

  16 Mar 2012

• REC opinion

  Further Information Favourable Opinion