A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
- Conditions
- Healthy Volunteers - Haemophilia A
- Interventions
- Drug: Mim8 B, 10 mg/mLDrug: Mim8 B, 100 mg/mLDrug: Mim8 B, placebo
- Registration Number
- NCT05127473
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).
This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.
Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.
The study will last for about 17 - 21 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive)
- Body weight between 60.0 to 100.0 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.
-
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
-
Factor VIII activity greater than or equal to150% at screening
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose level 4 Mim8 B, 10 mg/mL All participants will receive a single dose of Mim8 Dose level 3 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 5 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 9 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 2 Mim8 B, 10 mg/mL All participants will receive a single dose of Mim8 Dose level 8 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 11 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 1 Mim8 B, 10 mg/mL All participants will receive a single dose of Mim8 Dose level 1 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 6 Mim8 B, 10 mg/mL All participants will receive a single dose of Mim8 Dose level 7 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 12 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 3 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 5 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 9 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 10 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8 Dose level 11 Mim8 B, placebo All participants will receive a single dose of Mim8 Dose level 8 Mim8 B, 100 mg/mL All participants will receive a single dose of Mim8
- Primary Outcome Measures
Name Time Method Number of treatment-emergent adverse events From time of dosing (day 1) to day 113 Count
- Secondary Outcome Measures
Name Time Method AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose From time of dosing (day 1) to day 113 messured in μg\*day/mL
Change in activated partial thromboplastin time From baseline (day 1) to day 113 messured in seconds
Number of injection site reactions From time of dosing (day 1) to day 113 Count
Cmax, SD: the maximum concentration of Mim8 after a single dose From time of dosing (day 1) to day 113 messured in μg/mL
tmax, SD: the time to maximum concentration of Mim8 after a single dose From time of dosing (day 1) to day 113 messured in days
t1/2, SD: the terminal half-life of Mim8 after a single dose From time of dosing (day 1) to day 113 messured in days
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany