Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: Caplacizumab

• Registration Number: NCT02189733
• Lead Sponsor: Ablynx, a Sanofi company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Primary Completion: 2014-09
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Caplacizumab - Treatment B	Caplacizumab	Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab
Caplacizumab - Treatment A	Caplacizumab	Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: concentration of caplacizumab in plasma	Day 1 (pre-dose) until Day 7

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom