VOYAGER2Inno8 for Haemophilia A Safety and Tolerability
NNC0442-0344 A
Blood Coagulation Disorders+6
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: October 23, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on evaluating a new medicine called Inno8 for individuals with hemophilia A, a condition that affects the blood's ability to clot properly. The primary goal is to determine the safety and tolerability of different doses of Inno8 when taken orally. This research is significant because it could lead to a new treatment option for hemophilia A, potentially improving the quality of life for those affected by this condition. Participants in the study will receive multiple doses of Inno8 over the course of approximately 11 weeks. The study aims to observe how the medicine behaves in the body and its effects on the participants. Researchers will closely monitor participants for any side effects or changes in their health to ensure the treatment is safe. This process will help gather important information on the best dosage and potential benefits of Inno8 for managing hemophilia A.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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/m\^2). * 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. * Any known coagulation disorders other than haemophilia A. * Ongoing or planned immune tolerance induction therapy. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
Indiana Hemophilia-Thromb Ctr
Indianapolis, United StatesOpen Indiana Hemophilia-Thromb Ctr in Google MapsUniversity of Iowa_Iowa City
Iowa City, United StatesPenn State MS Hershey Med Ctr
Hershey, United StatesUniversitätsklinik für Innere Medizin V
Innsbruck, Austria