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Completed

NCT Number: NCT01228669

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

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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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Healthy Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC 0172-0000-2021

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: from trial product administration until 43 days after trial product administration

Secondary outcomes

  1. Area under the concentration-time curve

    Time frame: from 43 days after trial product administration until 53 days after trial product administration

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

    Time frame: from 43 days after trial product administration until 53 days after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: Explorer 1

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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