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Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B (Explorer 1)

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

NNC 0172-0000-2021

placebo

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse Events (AEs), including Serious Adverse Events (SAEs)

Secondary Outcome Measures

Area under the concentration-time curve

Adverse Events (AEs), including Serious Adverse Events (SAEs)

Full Information

NCT ID

NCT01228669

First Posted

October 25, 2010

Last Updated

May 14, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01228669

Brief Title

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

Acronym

Explorer 1

Official Title

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

October 25, 2010 (Actual)

Primary Completion Date

September 10, 2012 (Actual)

Study Completion Date

September 10, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC 0172-0000-2021

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NNC 0172-0000-2021

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of adverse Events (AEs), including Serious Adverse Events (SAEs)

Time Frame

from trial product administration until 43 days after trial product administration

Secondary Outcome Measure Information:

Title

Area under the concentration-time curve

Time Frame

from 43 days after trial product administration until 53 days after trial product administration

Title

Adverse Events (AEs), including Serious Adverse Events (SAEs)

Time Frame

from 43 days after trial product administration until 53 days after trial product administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

København

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt/M.

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20124

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

50400

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Polokwane

State/Province

Limpopo

ZIP/Postal Code

0699

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25641556

Citation

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.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B (Explorer 1)

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial