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

NCT03172208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Ablynx Clinical Department · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2017-10-19
Completion
2017-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172208 on ClinicalTrials.gov