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
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Novo Nordisk A/S
Start date
2023-01-02
Number of sites
- 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.
- 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
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-10-13
- First posted
- 2023-01-12
- Registry last updated
- 2025-10-14
- Primary completion date
- 2023-10-13
- Start date
- 2023-01-02
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05681845
- ClinicalTrials.gov ID
- NCT05681845
- Registry record
- Open registry record
- 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
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).
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.
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.
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.
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.
Number of injection site reactions
Timeframe: From time of dosing (day 1) to day 113
Measured in count of events.
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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
- Charité - Campus Charité Mitte - Charité Research Organisation GmbHBerlin, Germany
Sources for sites
- 2022-002318-18
- U1111-1277-9765
Sources for references
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Hemophilia A Primary condition