NCT02083666

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SOBI002	Test Product
DRUG	Placebo	Reference product

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-11-01
• Completion: 2015-02-01
• First posted: 2014-03-11
• Last updated: 2015-07-28

Locations

1 site across 1 country: United Kingdom