NCT03172208

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Caplacizumab Dose 1 iv (single-dose)	Single intravenous (iv) administration of Caplacizumab Dose 1
BIOLOGICAL	Caplacizumab Dose 2 iv (single-dose)	Single intravenous (iv) administration of Caplacizumab Dose 2
BIOLOGICAL	Caplacizumab Dose 2 sc (single-dose)	Single subcutaneous (sc) administration of Caplacizumab Dose 2
BIOLOGICAL	Caplacizumab Dose 2 sc (multiple-dose)	Once daily subcutaneous (sc) administration of Caplacizumab Dose 2 during 7 consecutive days
OTHER	Placebo iv (single-dose)	Single intravenous (iv) administration of Placebo
OTHER	Placebo sc (single-dose)	Single subcutaneous (sc) administration of Placebo
OTHER	Placebo sc (multiple-dose)	Once daily subcutaneous (sc) administration of Placebo during 7 consecutive days

Timeline

• Start date: 2017-06-05
• Primary completion: 2017-10-19
• Completion: 2017-10-19
• First posted: 2017-06-01
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study