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

Haemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05681845
• Other study ID #: NN7769-4992
• Secondary ID: U1111-1277-97652
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 13, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Haemophilia A
• Hemophilia A

Intervention

Drug:
• NNC0365-3769 (Mim8)
Participants will receive a single dose of Mim8 subcutaneously in the abdomen.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of injection site reactions	Measured in count of events.	From time of dosing (day 1) to day 113