A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men
- Registration Number
- NCT06649630
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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 is divided into two parts, called the single ascending dose (SAD) part and multiple ascending dose (MAD) part,...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 92
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (SAD): NNC0442-0344 A NNC0442-0344 A Participants will receive single dose of NNC0442-0344 A intravenously. Cohort 2 (SAD): NNC0442-0344 A NNC0442-0344 A Participants will receive single dose of NNC0442-0344 A intravenously. Cohort 3 (SAD): NNC0442-0344 A NNC0442-0344 A Participants will receive single dose of NNC0442-0344 A intravenously. Cohort 4 (SAD): NNC0442-0344 A NNC0442-0344 A Participants will receive single dose of NNC0442-0344 A intravenously. Cohort 5 (SAD): NNC0442-0344 A NNC0442-0344 A Participants will receive single dose of NNC0442-0344 A intravenously. Cohort 1 (MAD): NNC0442-0344 A NNC0442-0344 A Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Cohort 2 (MAD): NNC0442-0344 A NNC0442-0344 A Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Cohort 3 (MAD): NNC0442-0344 A NNC0442-0344 A Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Cohort 4 (MAD): NNC0442-0344 A NNC0442-0344 A Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. SAD: Placebo Placebo Participants will receive single dose of placebo intravenously. MAD: Placebo Placebo Participants will receive a oral daily dose of Placebo for 10 days.
- Primary Outcome Measures
Name Time Method SAD: Number of treatment emergent adverse events From time of dosing (Day 1) to Day 36 Measured as count of events.
MAD: Number of treatment emergent adverse events From time of dosing (Day 1) to end of follow-up (Day 46) Measured as count of events.
- Secondary Outcome Measures
Name Time Method MAD: Occurrence of anti-Inno8 antibodies From baseline (Day 1) to Day 46 Measured as count.
MAD: Cmax: The maximum concentration of Inno8 after multiple doses From Day 10 to Day 11 Measured as ng/mL.
MAD: Tmax: The time to Cmax after last multiple dose From Day 10 to Day 11 Measured as hours.
MAD: Tmax: The time to Cmax after first dose From Day 1 to Day 2 Measured as hours.
MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses From Day 10 to Day 11 Measured as ng\*day/mL.
MAD: Maximum thrombin generation (peak height) From Day 10 to Day 11 Measured as nM.
MAD: Change in fibrinogen From baseline (Day 1) to Day 46 Measured as absolute and %.
MAD: Change in platelets From baseline (Day 1) to Day 46 Measured as absolute and %.
MAD: Change in D-dimer From baseline (Day 1) to Day 46 Measured as absolute and %.
MAD: Change in prothrombin fragment 1 and 2 From baseline (Day 1) to Day 46 Measured as absolute and %.
SAD: Change in D-dimer From baseline (Day 1) to Day 36 Measured as absolute and percentage (%).
SAD: Change in prothrombin fragment 1 and 2 From baseline (Day 1) to Day 36 Measured as absolute and %.
SAD: Change in fibrinogen From baseline (Day 1) to Day 36 Measured as absolute and %.
SAD: Change in platelets From baseline (Day 1) to Day 36 Measured as absolute and %.
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose From baseline (Day 1) to Day 36 Measured as nanograms per millilitre (ng/mL).
SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose From baseline (Day 1) to Day 36 Measured as nanograms\*day per millilitre (ng\*day/mL).
SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose From baseline (Day 1) to Day 36 Measured as days.
SAD: Maximum change in activated partial thromboplastin time From baseline (Day 1) to Day 36 Measured as seconds.
SAD: Maximum thrombin generation (peak height) From baseline (Day 1) to Day 36 Measured as nanomolar (nM).
Trial Locations
- Locations (1)
Charité Research Organisation GmbH
🇩🇪Berlin, Germany