Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03172208
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-05-29
Brief Title:
Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects
Sponsor:
Ablynx a Sanofi company
Organization:
Ablynx a Sanofi company
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
To assess the safety and tolerability of single ascending intravenous iv doses a single subcutaneous sc dose of caplacizumab Part I and multiple sc doses of caplacizumab Part II in Japanese subjects
Secondary objectives
To compare the pharmacokinetic PK and pharmacodynamic PD profiles total vWFAg concentration levels vWFAg coagulation factor VIII FVIIIC and ristocetin cofactor activity RICO after single iv or sc 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 iv doses a single subcutaneous sc dose of caplacizumab Part I and multiple sc doses of caplacizumab Part II in Japanese subjects
Secondary objectives
To compare the pharmacokinetic PK and pharmacodynamic PD profiles total vWFAg concentration levels vWFAg coagulation factor VIII FVIIIC and ristocetin cofactor activity RICO after single iv or sc administration of caplacizumab in Japanese and White subjects
To evaluate the immunogenicity of caplacizumab anti-drug antibodies ADA in Japanese subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None