NCT05127473

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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers - Haemophilia A

Interventions

Type	Name	Description
DRUG	Mim8 B, 10 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.
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.
DRUG	Mim8 B, placebo	Placebo will be used to dilute the IMP to different Mim8 concentrations

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-05-14
• Completion: 2022-05-14
• First posted: 2021-11-19
• Last updated: 2023-11-01

Locations

2 sites across 1 country: Germany