Status:
COMPLETED
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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....
Eligibility Criteria
Inclusion
- Male Caucasians aged 18 to 55 years, inclusive.
- 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
- History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
- Others as defined in the protocol
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02189733
Start Date
July 1 2014
Last Update
November 14 2014
Active Locations (1)
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1
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS