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Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B

NCT ID: NCT01228669

Last Updated: 2019-05-15

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-25

Study Completion Date

2012-09-10

Brief Summary

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This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

NNC 0172-0000-2021

Intervention Type DRUG

Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose

B

Group Type EXPERIMENTAL

NNC 0172-0000-2021

Intervention Type DRUG

Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.

C

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

Interventions

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NNC 0172-0000-2021

Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose

Intervention Type DRUG

NNC 0172-0000-2021

Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.

Intervention Type DRUG

placebo

Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight between 50 and 100 kg, both inclusive
* Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
* For haemophilia subjects only: Diagnosed with severe haemophilia A or B

Exclusion Criteria

* Known or suspected hypersensitivity to trial product(s) or related products
* Surgery planned to occur during the trial
* Any major and/or orthopaedic surgery within 30 days prior to trial product administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Copenhagen, , Denmark

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt/M., , Germany

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Kuala Lumpur, , Malaysia

Site Status

Novo Nordisk Investigational Site

Polokwane, Limpopo, South Africa

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Harrow, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Austria Denmark Germany Italy Malaysia South Africa Spain Sweden Switzerland Thailand United Kingdom

References

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Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martin-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy volunteers and patients with hemophilia: a randomized first human dose trial. J Thromb Haemost. 2015 May;13(5):743-54. doi: 10.1111/jth.12864. Epub 2015 Apr 6.

Reference Type RESULT
PMID: 25641556 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2010-020465-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1116-2356

Identifier Type: OTHER

Identifier Source: secondary_id

NN7415-3813

Identifier Type: -

Identifier Source: org_study_id

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