A Phase 1 interventional study of NNC0365-3769 (Mim8) in Haemophilia A, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 205 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.
Drug: NNC0365-3769 (Mim8)
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
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.
Drug: NNC0365-3769 (Mim8)
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Drug: NNC0365-3769 (Mim8)
Participants will receive a single dose of Mim8 subcutaneously in the abdomen.
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).
Time frame: From time of dosing (day 1) to day 113
Cmax, SD: maximum plasma concentration of Mim8 after a single dose
Measured in μg/mL.
Time frame: From time of dosing (day 1) to day 113
AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single
Measured in μg\*day/mL.
Time frame: 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.
Time frame: 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.
Time frame: From time of dosing (day 1) to day 113
Number of injection site reactions
Measured in count of events.
Time frame: From time of dosing (day 1) to day 113
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S