Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
NCT ID: NCT02189733
Last Updated: 2014-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-07-31
Brief Summary
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The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Caplacizumab - Treatment A
Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab
Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Caplacizumab - Treatment B
Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab
Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Interventions
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Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Eligibility Criteria
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Inclusion Criteria
* Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
* Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
* Others as defined in the protocol.
Exclusion Criteria
* History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
* Others as defined in the protocol
18 Years
55 Years
MALE
Yes
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Michel Paillarse, MD
Role: STUDY_DIRECTOR
Ablynx, a Sanofi company
Locations
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Quotient Clinical
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2014-001294-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0681-C102
Identifier Type: -
Identifier Source: org_study_id