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NCT Number: NCT05127473

A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

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.

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Key information

Conditions

Healthy Volunteers - Haemophilia A

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Mainz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mim8 B, 10 mg/mL

Drug

All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.

Other names: NN0365-3769

Mim8 B, 100 mg/mL

Drug

All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.

Other names: NN0365-3769

Mim8 B, placebo

Drug

Placebo will be used to dilute the IMP to different Mim8 concentrations

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: From time of dosing (day 1) to day 113

    Count

Secondary outcomes

  1. Number of injection site reactions

    Time frame: From time of dosing (day 1) to day 113

    Count

  2. Cmax, SD: the maximum concentration of Mim8 after a single dose

    Time frame: From time of dosing (day 1) to day 113

    messured in μg/mL

  3. AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose

    Time frame: From time of dosing (day 1) to day 113

    messured in μg*day/mL

  4. t1/2, SD: the terminal half-life of Mim8 after a single dose

    Time frame: From time of dosing (day 1) to day 113

    messured in days

  5. tmax, SD: the time to maximum concentration of Mim8 after a single dose

    Time frame: From time of dosing (day 1) to day 113

    messured in days

  6. Change in activated partial thromboplastin time

    Time frame: From baseline (day 1) to day 113

    messured in seconds

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.