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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.
SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, Germany
Charité Research Organisation GmbH
Berlin, Germany
SAD: Number of treatment emergent adverse events
Measured as count of events.
Time frame: From time of dosing (Day 1) to Day 36
MAD: Number of treatment emergent adverse events
Measured as count of events.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
SSD: Number of treatment emergent adverse events
Measured as count of events.
Time frame: From time of dosing (Day 1) to Day 36
SAD: Change in D-dimer
Measured as absolute and percentage (%).
Time frame: From baseline (Day 1) to Day 36
SAD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SAD: Change in fibrinogen
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SAD: Change in platelets
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Measured as nanograms per millilitre (ng/mL).
Time frame: From baseline (Day 1) to Day 36
SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Measured as nanograms\*day per millilitre (ng\*day/mL).
Time frame: From baseline (Day 1) to Day 36
SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Measured as days.
Time frame: From baseline (Day 1) to Day 36
SAD: Maximum change in activated partial thromboplastin time
Measured as seconds.
Time frame: From baseline (Day 1) to Day 36
SAD: Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Time frame: From baseline (Day 1) to Day 36
MAD: Change in D-dimer
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
MAD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
MAD: Change in fibrinogen
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
MAD: Change in platelets
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
MAD: Occurrence of anti-Inno8 antibodies
Measured as count.
Time frame: From baseline (Day 1) to Day 46
MAD: Cmax: The maximum concentration of Inno8 after multiple doses
Measured as ng/mL.
Time frame: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after last multiple dose
Measured as hours.
Time frame: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after first dose
Measured as hours.
Time frame: From Day 1 to Day 2
MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Measured as ng\*day/mL.
Time frame: From Day 10 to Day 11
MAD: Maximum thrombin generation (peak height)
Measured as nM.
Time frame: From Day 10 to Day 11
SSD: Change in D-dimer
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SSD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SSD: Change in fibrinogen
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SSD: Change in platelets
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Measured as ng/mL.
Time frame: From baseline (Day 1) to Day 36
SSD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Measured as ng\*day/mL.
Time frame: From baseline (Day 1) to Day 36
SSD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Measured as days.
Time frame: From baseline (Day 1) to Day 36
SSD: Maximum change in activated partial thromboplastin time
Measured as seconds.
Time frame: From baseline (Day 1) to Day 36
SSD: Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Time frame: From baseline (Day 1) to Day 36
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