Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/16/2017 |
| Start Date: | June 5, 2017 |
| End Date: | October 19, 2017 |
A Phase I Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Caplacizumab in Japanese and White Healthy Volunteers.
Primary objective:
To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single
subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab
(Part II) in Japanese subjects.
Secondary objectives:
- To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag
concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin
cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in
Japanese and White subjects.
- To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese
subjects.
To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single
subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab
(Part II) in Japanese subjects.
Secondary objectives:
- To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag
concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin
cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in
Japanese and White subjects.
- To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese
subjects.
Inclusion Criteria:
- BMI between ≥18 kg/m² and <30 kg/m² at time of screening
- Body weight between ≥45 kg and <100 kg
- Baseline vWF:Ag between ≥60% and <170% (0.6-1.7 IU/mL)
Exclusion Criteria:
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood
dyscrasia, including but not limited to thrombocytopenia, thrombocytopathy,
thromboasthenia, hemophilia, von Willebrand's disease, vascular purpura, bleeding gums
and/or frequent nose bleeding, easy/spontaneous bruises, meno- or metrorrhagia,
history of gastrointestinal bleeding or excessive bleeding after minor injury such as
shaving.
- Family history of congenital vascular malformation (e.g., Marfan's Syndrome) and/or
bleeding disorder (e.g., hemophilia, von Willebrand's disease, Christmas disease)
- Any surgical intervention (including tooth extraction) or trauma within the 4 weeks
preceding screening for the study or any planned surgical intervention during the
participation in the study
- Treatment with vitamin K, direct oral anticoagulant (DOAC), warfarin, high dose
heparin within 2 weeks before screening
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