Back to resultsA Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge
Primary Purpose
Haemophilia A
Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC0365-3769 (Mim8)
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia A
Eligibility Criteria
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).
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1 (Pilot part)
Arm 2 (Pilot part)
Arm 3 (Bioequivalence part)
Arm 4 (Bioequivalence part)
Arm Description
Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector.
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Outcomes
Primary Outcome Measures
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).
Cmax, SD: maximum plasma concentration of Mim8 after a single dose
Measured in μg/mL.
Secondary Outcome Measures
AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single
Measured in μg*day/mL.
t1/2, SD: the terminal half-life of Mim8 after a single dose
Measured in days.
tmax, SD: the time to maximum concentration of Mim8 after a single dose
Measured in days.
Number of injection site reactions
Measured in count of events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05681845
Brief 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
September 12, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study consists of two parts - an open-label pilot part and a double-blind bioequivalence part.
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 (Pilot part)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.
Arm Title
Arm 2 (Pilot part)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Arm Title
Arm 3 (Bioequivalence part)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector.
Arm Title
Arm 4 (Bioequivalence part)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Intervention Type
Drug
Intervention Name(s)
NNC0365-3769 (Mim8)
Intervention Description
Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
Primary Outcome Measure Information:
Title
AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose
Description
Measured in micrograms*day per milliliter (μg*day/mL).
Time Frame
From time of dosing (day 1) to day 113
Title
Cmax, SD: maximum plasma concentration of Mim8 after a single dose
Description
Measured in μg/mL.
Time Frame
From time of dosing (day 1) to day 113
Secondary Outcome Measure Information:
Title
AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single
Description
Measured in μg*day/mL.
Time Frame
From time of dosing (day 1) to day 113
Title
t1/2, SD: the terminal half-life of Mim8 after a single dose
Description
Measured in days.
Time Frame
From time of dosing (day 1) to day 113
Title
tmax, SD: the time to maximum concentration of Mim8 after a single dose
Description
Measured in days.
Time Frame
From time of dosing (day 1) to day 113
Title
Number of injection site reactions
Description
Measured in count of events.
Time Frame
From time of dosing (day 1) to day 113
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
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
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