An Open, Non-controlled, Parallel, Ascending Multiple-dose, Multicenter Study to Assess Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI003 in Pediatric MPS IIIA Patients

Trial Profile

An Open, Non-controlled, Parallel, Ascending Multiple-dose, Multicenter Study to Assess Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI003 in Pediatric MPS IIIA Patients

Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Feb 2018

At a glance

  • Drugs SOBI 003 (Primary)
  • Indications Mucopolysaccharidosis III
  • Focus Adverse reactions
  • Sponsors Swedish Orphan Biovitrum
  • Most Recent Events

    • 02 Feb 2018 Status changed from planning to not yet recruiting.
    • 23 Jan 2018 According to a Swedish Orphan Biovitrum media release, the FDA has issued a Study may proceed letter for this trial and accepted the investigational new drug (IND) application.
    • 24 Oct 2016 New trial record
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