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

May 14, 2019 updated by: Novo Nordisk A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
  • Denmark
      • København, Denmark, 2100
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk Investigational Site
  • Italy
      • Milano, Italy, 20124
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • South Africa
    • Limpopo
      • Polokwane, Limpopo, South Africa, 0699
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Novo Nordisk Investigational Site
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 7EH
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W12 0NN
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: NNC 0172-0000-2021
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
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.
EXPERIMENTAL: A
Drug: NNC 0172-0000-2021
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
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.
PLACEBO_COMPARATOR: C
Drug: placebo
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
Time Frame: from trial product administration until 43 days after trial product administration
from trial product administration until 43 days after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve
Time Frame: from 43 days after trial product administration until 53 days after trial product administration
from 43 days after trial product administration until 53 days after trial product administration
Adverse Events (AEs), including Serious Adverse Events (SAEs)
Time Frame: from 43 days after trial product administration until 53 days after trial product administration
from 43 days after trial product administration until 53 days after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 25, 2010

Primary Completion (ACTUAL)

September 10, 2012

Study Completion (ACTUAL)

September 10, 2012

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (ESTIMATE)

October 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7415-3813
  • 2010-020465-24 (EUDRACT_NUMBER)
  • U1111-1116-2356 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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