A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-26

Study Completion Date

2012-09-04

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

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Detailed Description

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The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.

Conditions

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Congenital Bleeding Disorder Haemophilia A Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose (healthy subjects)

Group Type EXPERIMENTAL

NNC172-2021

Intervention Type DRUG

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

Medium dose (subjects with haemophilia)

Group Type EXPERIMENTAL

NNC172-2021

Intervention Type DRUG

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

High dose (subjects with haemophilia)

Group Type EXPERIMENTAL

NNC172-2021

Intervention Type DRUG

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

Interventions

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NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria

* Known or suspected hypersensitivity to trial product(s) or related products
* Thrombocyte count below the lower limit of normal range at screening
* Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes