A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men (VOYAGER1)

Novo Nordisk

Status and phase

Enrolling

Phase 1

Conditions

Haemophilia A

Treatments

Drug: NNC0442-0344 A

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06649630

NN7442-7582

2023-506520-90 (Other Identifier)

U1111-1292-7153 (Other Identifier)

Details and patient eligibility

About

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 consists of three parts: single ascending dose (SAD), multiple ascending dose (MAD) and single subcutaneous dose (SSD). 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 be prescribed by doctors. In the SAD and SSD 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.

Enrollment

108 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male
Age 18-45 years (both inclusive) at the time of signing informed consent
Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive)
Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Factor VIII activity greater than or equal to (≥) 150% at screening
Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis
Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
Any of the thrombophilia markers listed below:
Protein C, protein S or antithrombin below the lower normal laboratory range
Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

108 participants in 14 patient groups, including a placebo group

Cohort 1 (SAD): NNC0442-0344 A

Experimental group

Description: