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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: SOBI002 Drug: Placebo||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Single and repeated administration of different doses of test product
Placebo Comparator: placebo
Single and repeated administration of placebo comparator
- 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.
- Assessment of pharmacokinetics of SOBI002 through analysis of serum samples [ Time Frame: Up to 13 weeks ]
- Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity [ Time Frame: Up to 13 weeks ]
- Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies [ Time Frame: Up to 13 weeks ]
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
|Richmond Pharmacology Ltd.|
|London, St George's University of London, United Kingdom, SW17 0RE|
|Study Director:||Erik Brouwer, MD||Swedish Orphan Biovitrum AB (publ)|