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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
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.
Epistemonikos ID: 8c592f93722b08e629c2dcb2e7c7252715057cea
First added on: May 20, 2024