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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy
• Interventions: Drug: NNC 0172-0000-2021; Drug: placebo

• Registration Number: NCT01228669
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10-25
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2012-09-10
• Study Completion: 2012-09-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	NNC 0172-0000-2021	-
B	NNC 0172-0000-2021	-
C	placebo	-

Primary Outcome Measures

Name	Time	Method
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)	from trial product administration until 43 days after trial product administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Manchester, United Kingdom