NCT06649630CompletedPhase 1
A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study consists of three parts: single ascending dose (SAD), multiple ascending dose (MAD) and single subcutaneous dose (SSD). Each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot be prescribed by doctors. In the SAD and SSD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 14 Oct 2024
- Start date
- 23 Sept 2024
- Primary completion date
- 26 Mar 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT06649630
- EU CT number
- 2023-506520-90-00
- EudraCT number
- 2023-506520-90
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 95
- From 23 Sept 2024 to the primary completion date, 26 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Protein C, protein S or antithrombin below the lower normal laboratory range
- Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
Other
- Factor VIII activity greater than or equal to (≥) 150% at screening
- Any of the thrombophilia markers listed below:
Who the study is looking for
- Male
- Age 18-45 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive)
- Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.