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.

Ablynx, a Sanofi company1 site in 1 country24 target enrollmentJuly 2014

ConditionsHealthy Volunteers

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Ablynx, a Sanofi company
Enrollment: 24
Locations: 1
Primary Endpoint: Pharmacokinetics: concentration of caplacizumab in plasma
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Ablynx, a Sanofi company

Responsible Party

Sponsor

Eligibility Criteria

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 -
•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

Outcomes

Primary Outcomes

Pharmacokinetics: concentration of caplacizumab in plasma

Time Frame: Day 1 (pre-dose) until Day 7

Secondary Outcomes

Pharmacodynamics as measured by Ristocetin cofactor activity in plasma(During screening until day 29 +/-1)
Pharmacodynamics as measured by Factor VIII clotting activity in plasma(During screening until day 29 +/- 1)
Safety and Tolerability: safety markers(From signing of informed consent form until day 43 +/- 2)
Pharmacodynamics as measured by von Willebrand factor antigen in plasma(During screening until Day 29 +/- 1)