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

NCT05681845 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN7769-4992U1111-1277-97652022-002318-18
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  From time of dosing (day 1) to day 113

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

  From time of dosing (day 1) to day 113

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

  From time of dosing (day 1) to day 113

• Number of injection site reactions

  From time of dosing (day 1) to day 113

Study Arms (4)

Arm 1 (Pilot part)

EXPERIMENTAL

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)

Arm 2 (Pilot part)

EXPERIMENTAL

Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.

Drug: NNC0365-3769 (Mim8)

Arm 3 (Bioequivalence part)

EXPERIMENTAL

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)

Arm 4 (Bioequivalence part)

EXPERIMENTAL

Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.

Drug: NNC0365-3769 (Mim8)

Interventions

NNC0365-3769 (Mim8) DRUG

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

Arm 1 (Pilot part); Arm 2 (Pilot part); Arm 3 (Bioequivalence part); Arm 4 (Bioequivalence part)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study consists of two parts - an open-label pilot part and a double-blind bioequivalence part.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 12, 2023
• Study Start: January 2, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)