Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

Study Overview
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Brief Summary
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This trial is conducted globally. 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 concizumab administered subcutaneously to haemophilia A subjects.

Official Title
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A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Conditions
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Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
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* Drug: Concizumab
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records Age between 18 and 64 years both inclusive, at the time of signing informed consent Body weight between 50 and 100 kg, both inclusive Exclusion Criteria: Known or suspected hypersensitivity to trial product or related products Platelet count below 50x10^9/L at screening Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator Subjects at increased risk of cardiovascular disease as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Concizumab<br> | Drug: Concizumab<br>* Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) |  | From first trial drug administration (day 1) to 11 weeks after the first trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough level of concizumab |  | Prior to the last s.c. dose administration (day 42) | 
| Frequency of binding non-neutralizing anti-concizumab antibodies |  | From first trial drug administration (day 1) to 11 weeks after the first trial product administration |