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Completed

NCT Number: NCT06649630

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0442-0344 A

Drug

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

Drug

SAD: Placebo will be administered intravenously.

MAD: Placebo will be administered orally.

SSD: Placebo will be administered subcutaneously.

Primary outcomes

  1. SAD: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to Day 36

    Measured as count of events.

  2. 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.

  3. SSD: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to Day 36

    Measured as count of events.

Secondary outcomes

  1. SAD: Change in D-dimer

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and percentage (%).

  2. SAD: Change in prothrombin fragment 1 and 2

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  3. SAD: Change in fibrinogen

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  4. SAD: Change in platelets

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  5. 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).

  6. 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).

  7. 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.

  8. SAD: Maximum change in activated partial thromboplastin time

    Time frame: From baseline (Day 1) to Day 36

    Measured as seconds.

  9. SAD: Maximum thrombin generation (peak height)

    Time frame: From baseline (Day 1) to Day 36

    Measured as nanomolar (nM).

  10. MAD: Change in D-dimer

    Time frame: From baseline (Day 1) to Day 46

    Measured as absolute and %.

  11. MAD: Change in prothrombin fragment 1 and 2

    Time frame: From baseline (Day 1) to Day 46

    Measured as absolute and %.

  12. MAD: Change in fibrinogen

    Time frame: From baseline (Day 1) to Day 46

    Measured as absolute and %.

  13. MAD: Change in platelets

    Time frame: From baseline (Day 1) to Day 46

    Measured as absolute and %.

  14. MAD: Occurrence of anti-Inno8 antibodies

    Time frame: From baseline (Day 1) to Day 46

    Measured as count.

  15. MAD: Cmax: The maximum concentration of Inno8 after multiple doses

    Time frame: From Day 10 to Day 11

    Measured as ng/mL.

  16. MAD: Tmax: The time to Cmax after last multiple dose

    Time frame: From Day 10 to Day 11

    Measured as hours.

  17. MAD: Tmax: The time to Cmax after first dose

    Time frame: From Day 1 to Day 2

    Measured as hours.

  18. 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.

  19. MAD: Maximum thrombin generation (peak height)

    Time frame: From Day 10 to Day 11

    Measured as nM.

  20. SSD: Change in D-dimer

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  21. SSD: Change in prothrombin fragment 1 and 2

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  22. SSD: Change in fibrinogen

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  23. SSD: Change in platelets

    Time frame: From baseline (Day 1) to Day 36

    Measured as absolute and %.

  24. 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.

  25. 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.

  26. 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.

  27. SSD: Maximum change in activated partial thromboplastin time

    Time frame: From baseline (Day 1) to Day 36

    Measured as seconds.

  28. SSD: Maximum thrombin generation (peak height)

    Time frame: From baseline (Day 1) to Day 36

    Measured as nanomolar (nM).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: VOYAGER1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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