> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-the-blood-levels-of-mim8-in-healthy-men-d9cd9c37-86ae-4fb2-b9b8-808f2f1899ce > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Participants 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Start date 2023-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Dates **Completion date** 2023-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **First posted** 2023-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Registry last updated** 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Primary completion date** 2023-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Start date** 2023-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Size and sites **Actual participants** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Participants** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Identifiers **Registry ID** NCT05681845 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **ClinicalTrials.gov ID** NCT05681845 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** The study consists of two parts - an open-label pilot part and a double-blind bioequivalence part. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Outcomes ### 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: From time of dosing (day 1) to day 113 Measured in days. 4. Number of injection site reactions Timeframe: From time of dosing (day 1) to day 113 Measured in count of events. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Sites - Charité - Campus Charité Mitte - Charité Research Organisation GmbHBerlin, Germany Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## References ### Other registry identifiers (2) - 2022-002318-18 - U1111-1277-9765 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681845) ## Related records ### Drugs (1) - [Denecimig](https://trialight.com/data/asset/denecimig-6c082e13-91b6-4504-abfd-41125b68d81f.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Hemophilia A](https://trialight.com/data/condition/hemophilia-a-f8870901-8872-5178-8d5a-e1fde5d3339e.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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