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Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

Healthy Clinical Trial

Official 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

Clinical Trial Summary

The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.

Clinical Trial 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 placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02083666
Study type Interventional
Source Swedish Orphan Biovitrum
Contact
Status Terminated
Phase Phase 1
Start date December 2013
Completion date February 2015
View Details
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