Clinical trial NCT06649630: A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Oral Doses of Inno8 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, and 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 yet be prescribed by doctors. In the SAD 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.


Eligibility criteria: 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

Primary outcomes:
measure: SAD: Number of treatment emergent adverse events
timeFrame: From time of dosing (Day 1) to Day 36
measure: MAD: Number of treatment emergent adverse events
timeFrame: From time of dosing (Day 1) to end of follow-up (Day 46)
Secondary outcomes:
measure: SAD: Change in D-dimer
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Change in prothrombin fragment 1 and 2
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Change in fibrinogen
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Change in platelets
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Maximum change in activated partial thromboplastin time
timeFrame: From baseline (Day 1) to Day 36
measure: SAD: Maximum thrombin generation (peak height)
timeFrame: From baseline (Day 1) to Day 36
measure: MAD: Change in D-dimer
timeFrame: From baseline (Day 1) to Day 46
measure: MAD: Change in prothrombin fragment 1 and 2
timeFrame: From baseline (Day 1) to Day 46
measure: MAD: Change in fibrinogen
timeFrame: From baseline (Day 1) to Day 46
measure: MAD: Change in platelets
timeFrame: From baseline (Day 1) to Day 46
measure: MAD: Occurrence of anti-Inno8 antibodies
timeFrame: From baseline (Day 1) to Day 46
measure: MAD: Cmax: The maximum concentration of Inno8 after multiple doses
timeFrame: From Day 10 to Day 11
measure: MAD: Tmax: The time to Cmax after last multiple dose
timeFrame: From Day 10 to Day 11
measure: MAD: Tmax: The time to Cmax after first dose
timeFrame: From Day 1 to Day 2
measure: MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
timeFrame: From Day 10 to Day 11
measure: MAD: Maximum thrombin generation (peak height)
timeFrame: From Day 10 to Day 11
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: