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 Details — Status: Terminated

Administrative data

• NCT number: NCT02083666
• Other study ID #: SOBI002-001
• Status: Terminated
• Phase: Phase 1
• First received: January 15, 2014
• Last updated: July 27, 2015
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SOBI002
Test Product
• Placebo
Reference product

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd.	London	St George's University of London

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum	Richmond Pharmacology Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration	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.	Up to 13 weeks	No
Secondary	Assessment of pharmacokinetics of SOBI002 through analysis of serum samples		Up to 13 weeks	No
Secondary	Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity		Up to 13 weeks	No
Secondary	Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies		Up to 13 weeks	No