Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT03172208
- Run by
- Ablynx, a Sanofi company
- People needed
- 60
- Starts
- 2017-06-05
- Expected to finish
- 2017-10-19
- Last updated by the study team
- 2017-11-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Investigator Site — Glendale, California, United States
Full record on ClinicalTrials.gov
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