Safety tolerability PK and PD of SC and IV SOBI002

• Research type

  Research Study

• Full title

  Safety, tolerability, pharmacokinetics and pharmacodynamics of SOBI002 following subcutaneous and intravenous administration. A double-blind, placebo-controlled, randomized within dose cohort, single and repeated dose-escalation study in healthy volunteers

• IRAS ID

  137617

• Sponsor organisation

  Swedish Orphan Biovitrum AB

• Eudract number

  2013-002738-19

• Research summary

  The sponsor of the study (SOBI) has confirmed that they wish to withhold permission to publish the research summary wording at this time. A The sponsor is aware that the study needs to published on a public website 6 weeks after first subject is screened at the latest and will do so on clinicaltrials.gov.uk

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/1188

• Date of REC Opinion

  3 Oct 2013

• REC opinion

  Favourable Opinion