VOYAGER2: Safety, Tolerability, PK/PD, dose-ascending Inno8 study in People with Haemophilia A.
Research type
Research Study
Full title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People with Haemophilia A.
IRAS ID
1012230
Contact name
Clinical Transparency ((Dept 2834)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2025-520490-38
ISRCTN Number
Not applicable
Research summary
We are doing this study to see if the study medicine (Inno8) is safe to use in people with haemophilia A. Haemophilia is a bleeding disorder that some people are born with where they bleed for longer than usual. People with haemophilia A have too little of a certain component in their blood called coagulation factor VIII, which helps to form blood clots to stop bleeding. Usually, medicines used to treat haemophilia A are injected with a needle into a vein or under the skin. However, some people with haemophilia A develop a resistance to these treatments by producing a type of protein called an inhibitor that stops these medicines from working. Inno8 is a tablet taken by mouth, developed to treat haemophilia A either with or without inhibitors. The safety of Inno8 is being tested in healthy volunteers at low doses in another study, and now will be tested in people with haemophilia A at similar and higher doses. The study results will help decide if Inno8 should be further tested as a treatment for haemophilia A.
The study will last for up to 11 weeks, including: up to 4 weeks before the first dose to see if the potential participant can take part in the study, taking Inno8 tablets for 10 days, and then follow-up for 35 days. During the visits, participants will complete a total of 17 visits either at the clinic, answer phone/video calls, or a nurse may visit them at home to assess their general health and take blood samples.
The study consists of 2 groups of participants. Each group is planned to have 10 participants. The dose of Inno8 given to participants in the first group is the same as the one already proven to be safe in healthy volunteers. The dose of Inno8 given to participants in the second group is higher than the one given in the first group.
Participants are men between 18–64 years, with a diagnosis of haemophilia A present from birth, and must have a body weight above 45 kg and a body mass index (BMI) of less than 30.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0454
Date of REC Opinion
1 Sep 2025
REC opinion
Further Information Favourable Opinion