A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

ConditionHaemophilia A
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-64
SponsorNovo Nordisk A/S

About this trial

This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male

Age 18-64 years (both inclusive) at the time of signing the informed consent.

Body weight greater than or equal to (≥) 45 kilograms (kgs).

Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.

Disqualifiers

Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.

Body mass index ≥30.0 kilogram per square meter (kg/m²).

Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.

Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • NNC0442-0344 A

    Drug

    NNC0442-0344 A will be administered orally.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of treatment emergent adverse events

Measured as count of events.

Time frame
From time of dosing (Day 1) to end of follow-up (Day 46)

Secondary outcomes

1

Change in D-dimer

Measured as absolute and percentage (%).

Time frame
From time of dosing (Day 1) to end of follow-up (Day 46)
2

Change in prothrombin fragment 1 and 2

Measured as absolute and %.

Time frame
From time of dosing (Day 1) to end of follow-up (Day 46)
3

Change in fibrinogen

Measured as absolute and %.

Time frame
From time of dosing (Day 1) to end of follow-up (Day 46)
4

Change in platelets

Measured as absolute and %.

Time frame
From time of dosing (Day 1) to end of follow-up (Day 46)

Other outcomes

Sponsors and contacts

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