Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

NCT02189733 | Completed Phase 1

• 2 other identifiers: ALX0681-C1022014-001294-13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: concentration of caplacizumab in plasma

  Day 1 (pre-dose) until Day 7

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Caplacizumab - Treatment A

EXPERIMENTAL

Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab

Biological: Caplacizumab

Caplacizumab - Treatment B

EXPERIMENTAL

Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab

Biological: Caplacizumab

Interventions

Caplacizumab BIOLOGICAL

Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab

Caplacizumab - Treatment A; Caplacizumab - Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

caplacizumab

Study Officials

• Jean-Michel Paillarse, MD

  Ablynx, a Sanofi company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Last Updated: November 14, 2014

Record last verified: 2014-07

Locations

GB (1)