A Phase 1 interventional study of Mim8 B, 10 mg/mL and Mim8 B, 100 mg/mL in Healthy Volunteers - Haemophilia A, sponsored by Novo Nordisk A/S. Completed at 2 sites in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 66 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:
Any of the thrombophilia markers listed below:
All participants will receive a single dose of Mim8
Drug: Mim8 B, 10 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 10 mg/mL
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 10 mg/mL
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 10 mg/mL
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL · Drug: Mim8 B, placebo
All participants will receive a single dose of Mim8
Drug: Mim8 B, 100 mg/mL
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.
Also known as: 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.
Also known as: NN0365-3769
Placebo will be used to dilute the IMP to different Mim8 concentrations
Number of treatment-emergent adverse events
Count
Time frame: From time of dosing (day 1) to day 113
Number of injection site reactions
Count
Time frame: From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose
messured in μg/mL
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
messured 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
messured 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
messured in days
Time frame: From time of dosing (day 1) to day 113
Change in activated partial thromboplastin time
messured in seconds
Time frame: From baseline (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 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S