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

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ClinicalTrials.gov Identifier: NCT02083666
Recruitment Status : Terminated (Transient adverse events observed)
First Posted : March 11, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SOBI002 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: SOBI002
Single and repeated administration of different doses of test product
Drug: SOBI002
Test Product

Placebo Comparator: placebo
Single and repeated administration of placebo comparator
Drug: Placebo
Reference product




Primary Outcome Measures :
  1. To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration [ Time Frame: 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 :
  1. Assessment of pharmacokinetics of SOBI002 through analysis of serum samples [ Time Frame: Up to 13 weeks ]
  2. Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity [ Time Frame: Up to 13 weeks ]
  3. Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies [ Time Frame: Up to 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083666


Locations
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United Kingdom
Richmond Pharmacology Ltd.
London, St George's University of London, United Kingdom, SW17 0RE
Sponsors and Collaborators
Swedish Orphan Biovitrum
Richmond Pharmacology Limited
Investigators
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Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum AB (publ)
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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT02083666    
Other Study ID Numbers: SOBI002-001
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Swedish Orphan Biovitrum:
Phase I
Dose cohorts
Escalating dose
Single dose
Multiple dose
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
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