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

Study Overview
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Brief Summary
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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

Official Title
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A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

Conditions
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Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy

Intervention / Treatment
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* Drug: NNC 0172-0000-2021
* Drug: NNC 0172-0000-2021
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: NNC 0172-0000-2021<br>* Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose<br>|
| Experimental: B<br> | Drug: NNC 0172-0000-2021<br>* Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.<br>|
| Placebo Comparator: C<br> | Drug: placebo<br>* Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse Events (AEs), including Serious Adverse Events (SAEs) |  | from trial product administration until 43 days after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |