drugset / Trial / NCT05127473

A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

NCT05127473 ↗

Phase 1 Completed 66 enrolled Novo Nordisk A/S
RandomizedParallel-groupQuadruple-blindTreatment

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. 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.

Timeline

Start
2021-07-14
Primary completion
2022-05-14
Completion
2022-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Denecimig Monoclonal antibody 10 mg/ml Subcutaneous
Subject Denecimig Monoclonal antibody 100 mg/ml Subcutaneous

Indications