Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

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.

Inclusion Criteria:

• 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 Criteria:

• 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