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Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.

CompletedPhase 1

Sponsor: Ablynx, a Sanofi company

Conditions: Healthy Volunteers

Interventions: Caplacizumab Dose 1 iv (single-dose), Caplacizumab Dose 2 iv (single-dose), Caplacizumab Dose 2 sc (single-dose), Caplacizumab Dose 2 sc (multiple-dose), Placebo iv (single-dose)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Glendale, California, United States