Congenital Bleeding Disorder, Haemophilia A, Healthy
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGNNC172-2021
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events (AEs) | From first trial drug administration through trial day 35 |
Secondary
| Measure | Time frame |
|---|---|
| Local tolerability | After the last s.c. dose administration (trial day 15) |
| Thrombocyte count | After the last s.c. dose administration (trial day 15) |
| Trough level (Ctrough) | Prior to the last s.c. dose administration (trial day 15) |
Countries
Austria, France, Germany, Spain, United Kingdom
Outcome results
None listed