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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia A
• Intervention / Treatment: Drug: NNC0442-0344 A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH
  • Berlin, Germany, 10117
    • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (SAD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A intravenously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 2 (SAD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A intravenously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 3 (SAD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A intravenously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 4 (SAD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A intravenously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 5 (SAD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A intravenously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 1 (MAD): NNC0442-0344 A; Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 2 (MAD): NNC0442-0344 A; Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 3 (MAD): NNC0442-0344 A; Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 4 (MAD): NNC0442-0344 A; Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Placebo Comparator: SAD: Placebo; Participants will receive single dose of placebo intravenously.	Drug: Placebo; SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.
Placebo Comparator: MAD: Placebo; Participants will receive a oral daily dose of Placebo for 10 days.	Drug: Placebo; SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.
Experimental: Cohort 1 (SSD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A subcutaneously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Experimental: Cohort 2 (SSD): NNC0442-0344 A; Participants will receive single dose of NNC0442-0344 A subcutaneously.	Drug: NNC0442-0344 A; SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.; Other Names: Inno8
Placebo Comparator: SSD: Placebo; Participants will receive single dose of placebo subcutaneously.	Drug: Placebo; SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD: Number of treatment emergent adverse events	Measured as count of events.	From time of dosing (Day 1) to Day 36
MAD: Number of treatment emergent adverse events	Measured as count of events.	From time of dosing (Day 1) to end of follow-up (Day 46)
SSD: Number of treatment emergent adverse events	Measured as count of events.	From time of dosing (Day 1) to Day 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD: Change in D-dimer	Measured as absolute and percentage (%).	From baseline (Day 1) to Day 36
SAD: Change in prothrombin fragment 1 and 2	Measured as absolute and %.	From baseline (Day 1) to Day 36
SAD: Change in fibrinogen	Measured as absolute and %.	From baseline (Day 1) to Day 36
SAD: Change in platelets	Measured as absolute and %.	From baseline (Day 1) to Day 36
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose	Measured as nanograms per millilitre (ng/mL).	From baseline (Day 1) to Day 36
SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose	Measured as nanograms*day per millilitre (ng*day/mL).	From baseline (Day 1) to Day 36
SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose	Measured as days.	From baseline (Day 1) to Day 36
SAD: Maximum change in activated partial thromboplastin time	Measured as seconds.	From baseline (Day 1) to Day 36
SAD: Maximum thrombin generation (peak height)	Measured as nanomolar (nM).	From baseline (Day 1) to Day 36
MAD: Change in D-dimer	Measured as absolute and %.	From baseline (Day 1) to Day 46
MAD: Change in prothrombin fragment 1 and 2	Measured as absolute and %.	From baseline (Day 1) to Day 46
MAD: Change in fibrinogen	Measured as absolute and %.	From baseline (Day 1) to Day 46
MAD: Change in platelets	Measured as absolute and %.	From baseline (Day 1) to Day 46
MAD: Occurrence of anti-Inno8 antibodies	Measured as count.	From baseline (Day 1) to Day 46
MAD: Cmax: The maximum concentration of Inno8 after multiple doses	Measured as ng/mL.	From Day 10 to Day 11
MAD: Tmax: The time to Cmax after last multiple dose	Measured as hours.	From Day 10 to Day 11
MAD: Tmax: The time to Cmax after first dose	Measured as hours.	From Day 1 to Day 2
MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses	Measured as ng*day/mL.	From Day 10 to Day 11
MAD: Maximum thrombin generation (peak height)	Measured as nM.	From Day 10 to Day 11
SSD: Change in D-dimer	Measured as absolute and %.	From baseline (Day 1) to Day 36
SSD: Change in prothrombin fragment 1 and 2	Measured as absolute and %.	From baseline (Day 1) to Day 36
SSD: Change in fibrinogen	Measured as absolute and %.	From baseline (Day 1) to Day 36
SSD: Change in platelets	Measured as absolute and %.	From baseline (Day 1) to Day 36
SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose	Measured as ng/mL.	From baseline (Day 1) to Day 36
SSD: AUC, SD: the area under the concentration curve of Inno8 after a single dose	Measured as ng*day/mL.	From baseline (Day 1) to Day 36
SSD: T1/2, SD: the terminal half-life of Inno8 after a single dose	Measured as days.	From baseline (Day 1) to Day 36
SSD: Maximum change in activated partial thromboplastin time	Measured as seconds.	From baseline (Day 1) to Day 36
SSD: Maximum thrombin generation (peak height)	Measured as nanomolar (nM).	From baseline (Day 1) to Day 36

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): March 26, 2026
• Study Completion (Actual): March 26, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: NN7442-7582; U1111-1292-7153 (Other Identifier: Universal Trial Number); 2023-506520-90 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No