CompletedPhase 1

A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men

Germany95 participantsStarted 2024-09-23

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Factor VIII activity greater than or equal to (≥) 150% at screening * 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 of the thrombophilia markers listed below: * 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

What they're measuring

SAD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to Day 36

MAD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to end of follow-up (Day 46)

SSD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to Day 36

Trial details

NCT IDNCT06649630

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-26

View on ClinicalTrials.gov More Haemophilia A trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

SAD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to Day 36

MAD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to end of follow-up (Day 46)

SSD: Number of treatment emergent adverse events

Timeframe: From time of dosing (Day 1) to Day 36