Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
Conditions
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
Interventions
DRUGNNC 0172-0000-2021
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
DRUGplacebo
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse Events (AEs), including Serious Adverse Events (SAEs) | from trial product administration until 43 days after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Denmark, Germany, Italy, Malaysia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom
Outcome results
None listed