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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: SOBI002

• Registration Number: NCT02083666
• Lead Sponsor: Swedish Orphan Biovitrum

Brief 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Females of non-childbearing potential or males
• 18 to 45 years of age
• Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.

Exclusion Criteria

• Females of childbearing potential
• Clinically significant disease
• Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Single and repeated administration of placebo comparator
SOBI002	SOBI002	Single and repeated administration of different doses of test product

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration	Up to 13 weeks	Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables.

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity	Up to 13 weeks
Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies	Up to 13 weeks
Assessment of pharmacokinetics of SOBI002 through analysis of serum samples	Up to 13 weeks

Trial Locations

Locations (1)

Richmond Pharmacology Ltd.; 🇬🇧 London, St George's University of London, United Kingdom