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 (explorer™2)

Novo Nordisk

Status and phase

Terminated

Phase 1

Conditions

Healthy

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: NNC172-2021

Study type

Interventional

Funder types

Industry

Identifiers

NCT01631942

NN7415-3986

2011-005757-32 (EudraCT Number)

U1111-1126-0327 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

4 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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