Healthy Volunteers - Haemophilia APhase 1NCT05127473
A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
A Phase 1 study testing Mim8 B, 10 mg/mL and Mim8 B, 100 mg/mL in people with Healthy Volunteers - Haemophilia A, run by Novo Nordisk A/S at 2 sites in Germany.
Trial summary
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly). This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body. 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
- Healthy Volunteers - Haemophilia A
- What is being tested?
- Mim8 B, 10 mg/mL and Mim8 B, 100 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesGermany
- Study dates
- 14 Jul 2021to 14 May 2022
- 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 between 18.5 and 29.9 kg/m^2 (both inclusive)
- Body weight between 60.0 to 100.0 kg (both inclusive)
- 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 to150% at screening
- Any of the thrombophilia markers listed below:
- Protein C, protein S or antithrombin below the lower normal laboratory range
- Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).
This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.
Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.
The study will last for about 17 - 21 weeks.
- Conditions
- Healthy Volunteers - Haemophilia A
- Being tested
- Mim8 B, 10 mg/mL, Mim8 B, 100 mg/mL, Mim8 B, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mim8 B, 10 mg/mLDrug
Also called NN0365-3769
All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.
Mim8 B, 100 mg/mLDrug
Also called NN0365-3769
All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.
Mim8 B, placeboDrug
Placebo will be used to dilute the IMP to different Mim8 concentrations
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 10 mg/mL; Drug: Mim8 B, placebo |
| Dose level 2 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 10 mg/mL |
| Dose level 3 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, placebo |
| Dose level 4 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 10 mg/mL |
| Dose level 5 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, placebo |
| Dose level 6 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 10 mg/mL |
| Dose level 7 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL |
| Dose level 8 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, placebo |
| Dose level 9 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, placebo |
| Dose level 10 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL |
| Dose level 11 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, placebo |
| Dose level 12 | Experimental | All participants will receive a single dose of Mim8 Receives: Drug: Mim8 B, 100 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Count
Measured: From time of dosing (day 1) to day 113
Secondary outcomes (6)
Number of injection site reactions
Count
Measured: From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose
messured in μg/mL
Measured: From time of dosing (day 1) to day 113
AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
messured 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
messured 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
messured in days
Measured: From time of dosing (day 1) to day 113
Change in activated partial thromboplastin time
messured in seconds
Measured: From baseline (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 posted19 Nov 2021
- Study start14 Jul 2021
- Primary completion14 May 2022
- Study completion14 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127473
- Sponsor's protocol ID
- NN7769-4882
- Other IDs
- U1111-1266-4001, 2021-003182-35
- Status last verified
- Oct 2023
- First submitted
- 9 Nov 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05127473
- Acronym / sponsor ID
- NN7769-4882
- Conditions
- Healthy Volunteers - Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 14 May 2022 (actual)
- First posted
- 19 Nov 2021 (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.
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).
This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.
Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.
The study will last for about 17 - 21 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: Mim8 B, 10 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 2 | Experimental | Drug: Mim8 B, 10 mg/mLAll participants will receive a single dose of Mim8 |
| Dose level 3 | Experimental | Drug: Mim8 B, 100 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 4 | Experimental | Drug: Mim8 B, 10 mg/mLAll participants will receive a single dose of Mim8 |
| Dose level 5 | Experimental | Drug: Mim8 B, 100 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 6 | Experimental | Drug: Mim8 B, 10 mg/mLAll participants will receive a single dose of Mim8 |
| Dose level 7 | Experimental | Drug: Mim8 B, 100 mg/mLAll participants will receive a single dose of Mim8 |
| Dose level 8 | Experimental | Drug: Mim8 B, 100 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 9 | Experimental | Drug: Mim8 B, 100 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 10 | Experimental | Drug: Mim8 B, 100 mg/mLAll participants will receive a single dose of Mim8 |
| Dose level 11 | Experimental | Drug: Mim8 B, 100 mg/mL, Drug: Mim8 B, placeboAll participants will receive a single dose of Mim8 |
| Dose level 12 | Experimental | Drug: Mim8 B, 100 mg/mLAll participants will receive a single dose of Mim8 |
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 between 18.5 and 29.9 kg/m^2 (both inclusive)
- Body weight between 60.0 to 100.0 kg (both inclusive)
- 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 to150% at screening
- Any of the thrombophilia markers listed below:
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 |
|---|---|---|
| Mim8 B, 10 mg/mLAlso: NN0365-3769All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing. | Drug | Dose level 1, Dose level 2, Dose level 4, Dose level 6 |
| Mim8 B, 100 mg/mLAlso: NN0365-3769All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing. | Drug | Dose level 10, Dose level 11, Dose level 12, Dose level 3, Dose level 5, Dose level 7, Dose level 8, Dose level 9 |
| Mim8 B, placeboPlacebo will be used to dilute the IMP to different Mim8 concentrations | Drug | Dose level 1, Dose level 11, Dose level 3, Dose level 5, Dose level 8, Dose level 9 |
Primary outcome
Number of treatment-emergent adverse events
Time frame: From time of dosing (day 1) to day 113
Count
6 secondary outcomes
Number of injection site reactions
Time frame: From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose
Time frame: From time of dosing (day 1) to day 113
AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
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
Change in activated partial thromboplastin time
Time frame: From baseline (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 1 Nov 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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. 1452) study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mim8 B, 10 mg/mL and Mim8 B, 100 mg/mL in people with Healthy Volunteers - Haemophilia A, run by Novo Nordisk A/S at 2 sites 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of treatment-emergent adverse events (time frame: From time of dosing (day 1) to day 113). 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 1 Nov 2023.