Healthy Volunteers
Conditions
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.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.
Interventions
BIOLOGICALCaplacizumab
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
Sponsors
Ablynx, a Sanofi company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: concentration of caplacizumab in plasma | Day 1 (pre-dose) until Day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics as measured by Ristocetin cofactor activity in plasma | During screening until day 29 +/-1 | — |
| Safety and Tolerability: safety markers | From signing of informed consent form until day 43 +/- 2 | Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations |
| Pharmacodynamics as measured by von Willebrand factor antigen in plasma | During screening until Day 29 +/- 1 | — |
| Pharmacodynamics as measured by Factor VIII clotting activity in plasma | During screening until day 29 +/- 1 | — |
Countries
United Kingdom
Outcome results
None listed