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

NCT ID: NCT06649630

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2026-05-04

Brief Summary

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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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Detailed Description

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Conditions

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Haemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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Cohort 1 (SAD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A intravenously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 2 (SAD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A intravenously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 3 (SAD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A intravenously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 4 (SAD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A intravenously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 5 (SAD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A intravenously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 1 (MAD): NNC0442-0344 A

Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 2 (MAD): NNC0442-0344 A

Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 3 (MAD): NNC0442-0344 A

Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 4 (MAD): NNC0442-0344 A

Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 1 (SSD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A subcutaneously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

Cohort 2 (SSD): NNC0442-0344 A

Participants will receive single dose of NNC0442-0344 A subcutaneously.

Group Type EXPERIMENTAL

NNC0442-0344 A

Intervention Type 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.

SAD: Placebo

Participants will receive single dose of placebo intravenously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAD: Placebo will be administered intravenously.

MAD: Placebo will be administered orally.

SSD: Placebo will be administered subcutaneously.

MAD: Placebo

Participants will receive a oral daily dose of Placebo for 10 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAD: Placebo will be administered intravenously.

MAD: Placebo will be administered orally.

SSD: Placebo will be administered subcutaneously.

SSD: Placebo

Participants will receive single dose of placebo subcutaneously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAD: Placebo will be administered intravenously.

MAD: Placebo will be administered orally.

SSD: Placebo will be administered subcutaneously.

Interventions

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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.

Intervention Type DRUG

Placebo

SAD: Placebo will be administered intravenously.

MAD: Placebo will be administered orally.

SSD: Placebo will be administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

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Inno8

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, , Germany

Site Status RECRUITING

Charité Research Organisation GmbH

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Novo Nordisk

Role: CONTACT

[email protected]
(+1) 866-867-7178

Other Identifiers

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U1111-1292-7153

Identifier Type: OTHER

Identifier Source: secondary_id

2023-506520-90

Identifier Type: OTHER

Identifier Source: secondary_id

NN7442-7582

Identifier Type: -

Identifier Source: org_study_id

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