A Phase 1 interventional study of Caplacizumab in Healthy Volunteers, sponsored by Ablynx, a Sanofi company. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-14.
Sponsored by Ablynx, a Sanofi company (part of Sanofi) · Phase 1, Interventional, and Treatment
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.
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.
Ablynx, a Sanofi company is the lead sponsor of 25 studies on the registry; none are open to participants now.
First submitted before Ablynx became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab
Biological: Caplacizumab
Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab
Biological: Caplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Pharmacokinetics: concentration of caplacizumab in plasma
Time frame: Day 1 (pre-dose) until Day 7
Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
Time frame: During screening until day 29 +/-1
Safety and Tolerability: safety markers
Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations
Time frame: From signing of informed consent form until day 43 +/- 2
Pharmacodynamics as measured by von Willebrand factor antigen in plasma
Time frame: During screening until Day 29 +/- 1
Pharmacodynamics as measured by Factor VIII clotting activity in plasma
Time frame: During screening until day 29 +/- 1
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Caplacizumab