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

NCT06649630 | Completed Phase 1

• 3 other identifiers: NN7442-7582U1111-1292-71532023-506520-90
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (28)

• SAD: Change in D-dimer

  From baseline (Day 1) to Day 36

• SAD: Change in prothrombin fragment 1 and 2

  From baseline (Day 1) to Day 36

• SAD: Change in fibrinogen

  From baseline (Day 1) to Day 36

• SAD: Change in platelets

  From baseline (Day 1) to Day 36

• SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose

  From baseline (Day 1) to Day 36

Study Arms (14)

Cohort 1 (SAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 2 (SAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 3 (SAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 4 (SAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 5 (SAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 1 (MAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 2 (MAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 3 (MAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 4 (MAD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 1 (SSD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

Cohort 2 (SSD): NNC0442-0344 A

EXPERIMENTAL

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

Drug: NNC0442-0344 A

SAD: Placebo

PLACEBO COMPARATOR

Participants will receive single dose of placebo intravenously.

Drug: Placebo

MAD: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SSD: Placebo

PLACEBO COMPARATOR

Participants will receive single dose of placebo subcutaneously.

Drug: Placebo

Interventions

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.

Also known as: Inno8

Cohort 1 (MAD): NNC0442-0344 A; Cohort 1 (SAD): NNC0442-0344 A; Cohort 1 (SSD): NNC0442-0344 A; Cohort 2 (MAD): NNC0442-0344 A; Cohort 2 (SAD): NNC0442-0344 A; Cohort 2 (SSD): NNC0442-0344 A; Cohort 3 (MAD): NNC0442-0344 A; Cohort 3 (SAD): NNC0442-0344 A; Cohort 4 (MAD): NNC0442-0344 A; Cohort 4 (SAD): NNC0442-0344 A; Cohort 5 (SAD): NNC0442-0344 A

Placebo DRUG

SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.

MAD: Placebo; SAD: Placebo; SSD: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start: September 23, 2024
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)