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

NCT ID: NCT03172208

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2017-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1: Japanese - Caplacizumab Dose 1 iv (SD)

Single dose (SD) of Caplacizumab Dose 1 administered intravenously (iv) to Japanese participants

Group Type EXPERIMENTAL

Caplacizumab Dose 1 iv (single-dose)

Intervention Type BIOLOGICAL

Single intravenous (iv) administration of Caplacizumab Dose 1

Group 1: Japanese - Placebo iv (SD)

Single dose (SD) of Placebo administered intravenously (iv) to Japanese participants

Group Type PLACEBO_COMPARATOR

Placebo iv (single-dose)

Intervention Type OTHER

Single intravenous (iv) administration of Placebo

Group 2: Japanese - Caplacizumab Dose 2 iv (SD)

Single dose (SD) of Caplacizumab Dose 2 administered intravenously (iv) to Japanese participants

Group Type EXPERIMENTAL

Caplacizumab Dose 2 iv (single-dose)

Intervention Type BIOLOGICAL

Single intravenous (iv) administration of Caplacizumab Dose 2

Group 2: Japanese - Placebo iv (SD)

Single dose (SD) of Placebo administered intravenously (iv) to Japanese participants

Group Type EXPERIMENTAL

Placebo iv (single-dose)

Intervention Type OTHER

Single intravenous (iv) administration of Placebo

Group 2: White - Caplacizumab Dose 2 iv (SD)

Single dose (SD) of Caplacizumab Dose 2 administered intravenously (iv) to White participants

Group Type EXPERIMENTAL

Caplacizumab Dose 2 iv (single-dose)

Intervention Type BIOLOGICAL

Single intravenous (iv) administration of Caplacizumab Dose 2

Group 2: White - Placebo iv (SD)

Single dose (SD) of Placebo administered intravenously (iv) to White participants

Group Type PLACEBO_COMPARATOR

Placebo iv (single-dose)

Intervention Type OTHER

Single intravenous (iv) administration of Placebo

Group 3: Japanese - Caplacizumab Dose 2 sc (SD)

Single dose (SD) of Caplacizumab Dose 2 administered subcutaneously (sc) to Japanese participants

Group Type EXPERIMENTAL

Caplacizumab Dose 2 sc (single-dose)

Intervention Type BIOLOGICAL

Single subcutaneous (sc) administration of Caplacizumab Dose 2

Group 3: Japanese - Placebo sc (SD)

Single dose (SD) of Placebo administered subcutaneously (sc) to Japanese participants

Group Type PLACEBO_COMPARATOR

Placebo sc (single-dose)

Intervention Type OTHER

Single subcutaneous (sc) administration of Placebo

Group 3: White - Caplacizumab Dose 2 sc (SD)

Single dose (SD) of Caplacizumab Dose 2 administered subcutaneously (sc) to White participants

Group Type EXPERIMENTAL

Caplacizumab Dose 2 sc (single-dose)

Intervention Type BIOLOGICAL

Single subcutaneous (sc) administration of Caplacizumab Dose 2

Group 3: White - Placebo sc (SD)

Single dose (SD) Placebo administered subcutaneously (sc) to White participants

Group Type PLACEBO_COMPARATOR

Placebo sc (single-dose)

Intervention Type OTHER

Single subcutaneous (sc) administration of Placebo

Group 4: Japanese - Caplacizumab Dose 2 sc (MD)

Multiple doses (MD) of Caplacizumab Dose 2 administered subcutaneously (sc) to Japanese participants

Group Type EXPERIMENTAL

Caplacizumab Dose 2 sc (multiple-dose)

Intervention Type BIOLOGICAL

Once daily subcutaneous (sc) administration of Caplacizumab Dose 2 during 7 consecutive days

Group 4: Japanese - Placebo sc (MD)

Multiple doses (MD) of Placebo administered subcutaneously (sc) to Japanese participants

Group Type PLACEBO_COMPARATOR

Placebo sc (multiple-dose)

Intervention Type OTHER

Once daily subcutaneous (sc) administration of Placebo during 7 consecutive days

Interventions

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Caplacizumab Dose 1 iv (single-dose)

Single intravenous (iv) administration of Caplacizumab Dose 1

Intervention Type BIOLOGICAL

Caplacizumab Dose 2 iv (single-dose)

Single intravenous (iv) administration of Caplacizumab Dose 2

Intervention Type BIOLOGICAL

Caplacizumab Dose 2 sc (single-dose)

Single subcutaneous (sc) administration of Caplacizumab Dose 2

Intervention Type BIOLOGICAL

Caplacizumab Dose 2 sc (multiple-dose)

Once daily subcutaneous (sc) administration of Caplacizumab Dose 2 during 7 consecutive days

Intervention Type BIOLOGICAL

Placebo iv (single-dose)

Single intravenous (iv) administration of Placebo

Intervention Type OTHER

Placebo sc (single-dose)

Single subcutaneous (sc) administration of Placebo

Intervention Type OTHER

Placebo sc (multiple-dose)

Once daily subcutaneous (sc) administration of Placebo during 7 consecutive days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ablynx, a Sanofi company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ablynx Clinical Department

Role: STUDY_DIRECTOR

Ablynx, a Sanofi company

Locations

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Investigator Site

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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ALX0681-C103

Identifier Type: -

Identifier Source: org_study_id