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

March 27, 2026 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SAD: Number of treatment emergent adverse events
Time Frame: From time of dosing (Day 1) to Day 36
Measured as count of events.
From time of dosing (Day 1) to Day 36
MAD: Number of treatment emergent adverse events
Time Frame: From time of dosing (Day 1) to end of follow-up (Day 46)
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
Time Frame: From time of dosing (Day 1) to Day 36
Measured as count of events.
From time of dosing (Day 1) to Day 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAD: Change in D-dimer
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and percentage (%).
From baseline (Day 1) to Day 36
SAD: Change in prothrombin fragment 1 and 2
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SAD: Change in fibrinogen
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SAD: Change in platelets
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Time Frame: From baseline (Day 1) to Day 36
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
Time Frame: From baseline (Day 1) to Day 36
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
Time Frame: From baseline (Day 1) to Day 36
Measured as days.
From baseline (Day 1) to Day 36
SAD: Maximum change in activated partial thromboplastin time
Time Frame: From baseline (Day 1) to Day 36
Measured as seconds.
From baseline (Day 1) to Day 36
SAD: Maximum thrombin generation (peak height)
Time Frame: From baseline (Day 1) to Day 36
Measured as nanomolar (nM).
From baseline (Day 1) to Day 36
MAD: Change in D-dimer
Time Frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
From baseline (Day 1) to Day 46
MAD: Change in prothrombin fragment 1 and 2
Time Frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
From baseline (Day 1) to Day 46
MAD: Change in fibrinogen
Time Frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
From baseline (Day 1) to Day 46
MAD: Change in platelets
Time Frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
From baseline (Day 1) to Day 46
MAD: Occurrence of anti-Inno8 antibodies
Time Frame: From baseline (Day 1) to Day 46
Measured as count.
From baseline (Day 1) to Day 46
MAD: Cmax: The maximum concentration of Inno8 after multiple doses
Time Frame: From Day 10 to Day 11
Measured as ng/mL.
From Day 10 to Day 11
MAD: Tmax: The time to Cmax after last multiple dose
Time Frame: From Day 10 to Day 11
Measured as hours.
From Day 10 to Day 11
MAD: Tmax: The time to Cmax after first dose
Time Frame: From Day 1 to Day 2
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
Time Frame: From Day 10 to Day 11
Measured as ng*day/mL.
From Day 10 to Day 11
MAD: Maximum thrombin generation (peak height)
Time Frame: From Day 10 to Day 11
Measured as nM.
From Day 10 to Day 11
SSD: Change in D-dimer
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SSD: Change in prothrombin fragment 1 and 2
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SSD: Change in fibrinogen
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SSD: Change in platelets
Time Frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
From baseline (Day 1) to Day 36
SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Time Frame: From baseline (Day 1) to Day 36
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
Time Frame: From baseline (Day 1) to Day 36
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
Time Frame: From baseline (Day 1) to Day 36
Measured as days.
From baseline (Day 1) to Day 36
SSD: Maximum change in activated partial thromboplastin time
Time Frame: From baseline (Day 1) to Day 36
Measured as seconds.
From baseline (Day 1) to Day 36
SSD: Maximum thrombin generation (peak height)
Time Frame: From baseline (Day 1) to Day 36
Measured as nanomolar (nM).
From baseline (Day 1) to Day 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Haemophilia A

Clinical Trials on NNC0442-0344 A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings