A study to assess single and multiple doses of PolyCAb

• Research type

  Research Study

• Full title

  A Phase I Double-Blind, Randomised, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PolyCAb in Healthy Subjects Following Single Ascending Doses and One Cohort of Multiple Dosing

• IRAS ID

  163723

• Contact name

  K M Donaldson

• Sponsor organisation

  MicroPharm Ltd

• Eudract number

  2014-002623-96

• Duration of Study in the UK

  0 years, 4 months, 16 days

• Research summary

  CDI (Clostridium difficile infection) is a type of infection that can affect the digestive system. The incidence of CDI in the UK has increased since the late 1990s and CDI has become a major cause of morbidity and mortality amongst patients with hospital-acquired infections. The clinical signs and symptoms associated with CDI are the result of the action of two exotoxins, TcdA and TcdB, secreted by the bacteria.

  MicroPharm has been developing an immunotherapeutic product, PolyCab, for systemic administration to treat cases of severe CDI. This product is a preparation of ovine polyclonal antibodies (predominantly immunoglobulin G molecules, IgG) directed against the two main C. difficile toxins, TcdA and TcdB.

  This is the first time PolyCAb will be tested in humans. The purposes of this study are to assess the safety, tolerability, pharmacokinetics and immungenicity of PolyCAb in healthy subjects following single ascending doses and one cohort of multiple dosing.

  The study is in two parts. Part 1 (single ascending doses) will be conducted in up to 16 subjects (2 cohorts of 8 subjects). Part 2 (multiple dose) will be conducted in 1 cohort of 8 subjects. Subjects in Part 1 will undergo a screening period, in-patient dosing comprising 2 overnight stays (from Day -1 to Day 2), an out-patient assessment period and a follow-up visit. Subjects in Part 2 will undergo a screening period, in-patient dosing comprising 8 overnight stays (from Day -1 to Day 8), an out-patient assessment period and a follow-up visit.

  The population eligible to take part in the study are healthy male and female (of non-child bearing potential with negative pregnancy test at the screening visit) subjects between 18 and 70 years of age with at least 2 subjects in each cohort being over 60 years of age (the age group most at risk for severe CDI).

• REC name

  Wales REC 2

• REC reference

  14/WA/1168

• Date of REC Opinion

  26 Nov 2014

• REC opinion

  Further Information Favourable Opinion