Haemophilia APhase 1NCT05681845
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
A Phase 1 study testing NNC0365-3769 (Mim8) in people with Haemophilia A, run by Novo Nordisk A/S at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia A
- What is being tested?
- NNC0365-3769 (Mim8)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2023to 13 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117
About this study
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
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
- Being tested
- NNC0365-3769 (Mim8)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0365-3769 (Mim8)Drug
Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: NNC0365-3769 (Mim8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From time of dosing (day 1) to day 113
Cmax, SD: maximum plasma concentration of Mim8 after a single dose
Measured in μg/mL.
Measured: 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
Measured in μg*day/mL.
Measured: From time of dosing (day 1) to day 113
t1/2, SD: the terminal half-life of Mim8 after a single dose
Measured in days.
Measured: From time of dosing (day 1) to day 113
tmax, SD: the time to maximum concentration of Mim8 after a single dose
Measured in days.
Measured: From time of dosing (day 1) to day 113
Number of injection site reactions
Measured in count of events.
Measured: From time of dosing (day 1) to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start2 Jan 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681845
- Sponsor's protocol ID
- NN7769-4992
- Other IDs
- U1111-1277-9765, 2022-002318-18
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05681845
- Acronym / sponsor ID
- NN7769-4992
- Conditions
- Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Pilot part) | Experimental | Drug: NNC0365-3769 (Mim8)Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector. |
| Arm 2 (Pilot part) | Experimental | Drug: NNC0365-3769 (Mim8)Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
| Arm 3 (Bioequivalence part) | Experimental | Drug: NNC0365-3769 (Mim8)Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector. |
| Arm 4 (Bioequivalence part) | Experimental | Drug: NNC0365-3769 (Mim8)Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0365-3769 (Mim8)Participants will receive a single dose of Mim8 subcutaneously in the abdomen. | Drug | Arm 1 (Pilot part), Arm 2 (Pilot part), Arm 3 (Bioequivalence part), Arm 4 (Bioequivalence part) |
Primary outcome
AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose
Time frame: 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
Time frame: From time of dosing (day 1) to day 113
Measured in μg/mL.
4 secondary outcomes
AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single
Time frame: From time of dosing (day 1) to day 113
t1/2, SD: the terminal half-life of Mim8 after a single dose
Time frame: From time of dosing (day 1) to day 113
tmax, SD: the time to maximum concentration of Mim8 after a single dose
Time frame: From time of dosing (day 1) to day 113
Number of injection site reactions
Time frame: From time of dosing (day 1) to day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Haemophilia A
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0365-3769 (Mim8) in people with Haemophilia A, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose (time frame: From time of dosing (day 1) to day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.