What is Inno8 studying for haemophilia A?

Inno8 is being studied to understand how different doses work in people with haemophilia A and to evaluate its safety. Researchers want to learn how the drug behaves in the body and monitor any side effects during the study. The trial is sponsored by Novo Nordisk A/S and focuses on people with this bleeding disorder.

Who may be eligible for this haemophilia A clinical trial?

Men aged 18 to 64 years diagnosed with congenital haemophilia A and a certain level of factor VIII activity may be eligible. Participants must weigh at least 45 kilograms and not have recent prophylactic treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this haemophilia A clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to participation.

Actively Recruiting

Phase 1

Age: 18Years - 64Years

MALE

Healthy Volunteers

ID07220564

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of Inno8 in People With Haemophilia A

Led by Novo Nordisk A/S · Updated on 2026-04-24

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how different doses of a study medicine called Inno8 work in the bodies of people with haemophilia A. This study aims to see if Inno8 is safe for use in people with this condition. The study medicine is new and not yet available by prescription. The study will last about 11 weeks. Participants will receive oral doses of the study drug NNC0442-0344 A in three different groups, each getting a dose to test how the medicine acts in the body. All doses are given by mouth, and the study includes multiple ascending doses to monitor safety and how the drug is processed. During the study, participants will be closely monitored for any side effects or treatment emergent adverse events from the first day of dosing through day 46. Researchers will measure blood markers related to coagulation and immune response, such as D-dimer, prothrombin fragments, fibrinogen, platelets, and anti-Inno8 antibodies. They will also assess drug concentration levels and thrombin generation to understand the drugs effects. The total participation lasts about 11 weeks, including follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years

MALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male
Age 18 to 64 years at the time of signing consent
Body weight greater than or equal to 45 kilograms
Diagnosis of congenital haemophilia A with factor VIII activity less than or equal to 15%, with or without inhibitors, based on medical records

You will not qualify if you...

Current or prior prophylactic treatment for haemophilia A within 5 half-lives before screening
Body mass index of 30.0 kg/m² or higher
Increased risk of thrombosis, including personal or first-degree relative history of unprovoked deep vein thrombosis
Any signs or diagnosis of venous or arterial thromboembolic disease
Known coagulation disorders other than haemophilia A
Ongoing or planned immune tolerance induction therapy
Clinically significant gastrointestinal disorders affecting drug absorption as judged by investigator

Research Team

Novo Nordisk

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