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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT05681845•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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).

Locations (1)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, Germany

Key Dates

Start Date

January 2, 2023

Primary Completion Date

October 13, 2023

Completion Date

October 13, 2023

Last Updated

October 14, 2025

Enrollment

205

ACTUAL participants

Conditions

Haemophilia A

Interventions

NNC0365-3769 (Mim8)

DRUG

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

NCT06285071

Haemophilia AHaemophilia B

View study

ENROLLING_BY_INVITATION

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Haemophilia A, Haemophilia B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

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Register of Patients With haEmophilia A tReated With Afstyla®