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Completed

NCT Number: NCT05681845

A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge

Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.

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Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

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 (BMI) between 18.5 and 29.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
  • Body weight between 60.0 and 100.0 kg (both inclusive) at screening.
  • 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 to (≥) 150 percent (%) at screening.
  • Thrombophilia as identified by any of the below laboratory markers at screening:
  • Protein C, protein S or antithrombin less than (<) lower limit of normal (LLN)
  • Factor II activity or activated protein C resistance >upper limit of normal (ULN).

Treatment and study plan

NNC0365-3769 (Mim8)

Drug

Participants will receive a single dose of Mim8 subcutaneously in the abdomen.

Primary outcomes

  1. AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose

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

    Measured in micrograms*day per milliliter (μg*day/mL).

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

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

    Measured in μg/mL.

Secondary outcomes

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

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

    Measured in μg*day/mL.

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

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

    Measured in days.

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

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

    Measured in days.

  4. Number of injection site reactions

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

    Measured in count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study to Demonstrate Bioequivalence of a Single Subcutaneous Administration of NNC0365-3769 (Mim8) With the DV3407-C1 Pen Injector Versus a Syringe and Enhanced Cartridge in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Oct 14, 2025

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.

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