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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia A
• Intervention / Treatment: Drug: NNC0365-3769 (Mim8)

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (Pilot part); Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.	Drug: NNC0365-3769 (Mim8); Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
Experimental: Arm 2 (Pilot part); Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.	Drug: NNC0365-3769 (Mim8); Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
Experimental: Arm 3 (Bioequivalence part); Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector.	Drug: NNC0365-3769 (Mim8); Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
Experimental: Arm 4 (Bioequivalence part); Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.	Drug: NNC0365-3769 (Mim8); Participants will receive a single dose of Mim8 subcutaneously in the abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose	Measured in micrograms*day per milliliter (μg*day/mL).	From time of dosing (day 1) to day 113
Cmax, SD: maximum plasma concentration of Mim8 after a single dose	Measured in μg/mL.	From time of dosing (day 1) to day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single	Measured in μg*day/mL.	From time of dosing (day 1) to day 113
t1/2, SD: the terminal half-life of Mim8 after a single dose	Measured in days.	From time of dosing (day 1) to day 113
tmax, SD: the time to maximum concentration of Mim8 after a single dose	Measured in days.	From time of dosing (day 1) to day 113
Number of injection site reactions	Measured in count of events.	From time of dosing (day 1) to day 113

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A
• Other Study ID Numbers: NN7769-4992; U1111-1277-9765 (Other Identifier: World Health Organization (WHO)); 2022-002318-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No