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Blood disorder

A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men

Locations

Germany

Start date

23/09/2024

Identifiers

Trial ID NN7442-7582,
NCT number NCT06649630,
Eudract number Not Available

Summary

This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study is divided into two parts, called the single ascending dose (SAD) part and multiple ascending dose (MAD) part, and each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot yet be prescribed by doctors. In the SAD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.

Trial Overview:

Condition

Haemophilia A

Treatment

DRUG: NNC0442-0344 A

DRUG: Placebo

Study type

INTERVENTIONAL

Trial duration

Sep 23 2024 - Sep 04 2025

Participants

92

Phase

I

Are you eligible?

Gender

MALE

Age

18 to 45 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

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