Clinical trial NCT05127473: A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers - Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: From time of dosing (day 1) to day 113
Secondary outcomes:
measure: Number of injection site reactions
timeFrame: From time of dosing (day 1) to day 113
measure: Cmax, SD: the maximum concentration of Mim8 after a single dose
timeFrame: From time of dosing (day 1) to day 113
measure: AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
timeFrame: From time of dosing (day 1) to day 113
measure: t1/2, SD: the terminal half-life of Mim8 after a single dose
timeFrame: From time of dosing (day 1) to day 113
measure: tmax, SD: the time to maximum concentration of Mim8 after a single dose
timeFrame: From time of dosing (day 1) to day 113
measure: Change in activated partial thromboplastin time
timeFrame: From baseline (day 1) to day 113
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: