Recruitment

Recruitment Status
Terminated
Estimated Enrollment
80

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
18
Max Age
45
Gender
Both

Description

This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation. Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or place...

This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation. Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.

Locations

London, St George's University of London, SW17 0RE
London, St George's University of London, SW17 0RE

Tracking Information

NCT #
NCT02083666
Collaborators
Richmond Pharmacology Limited
Investigators
Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum AB (publ)