Recruiting
Phase 1

Inno8

Sponsor:

Novo Nordisk A/S

Code:

NCT07220564

Conditions

Haemophilia A

Eligibility Criteria

Sex: Male

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

NNC0442-0344 A

Study Details

Brief summary:

This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.

Conditions

Haemophilia A

Study ID

NCT07220564

Start date

Oct 23, 2025

Status verified date

Aug, 2026

Completion date

Feb 5, 2027

Anticipated

Primary completion date

Feb 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body weight greater than or equal to (≥) 45 kilograms (kgs).
  • Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.

Exclusion Criteria:

  • Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
  • Body mass index ≥30.0 kilogram per square meter (kg/m\^2).
  • 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 known coagulation disorders other than haemophilia A.
  • Ongoing or planned immune tolerance induction therapy.
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Participants will receive oral dose of NNC0442-0344 A.

experimental: Cohort 2

Participants will receive oral dose of NNC0442-0344 A.

experimental: Cohort 3

Participants will receive oral dose of NNC0442-0344 A.

Interventions

NNC0442-0344 A

NNC0442-0344 A will be administered orally.

Primary outcome measure

  • Number of treatment emergent adverse events [ Time Frame: From time of dosing (Day 1) to end of follow-up (Day 46) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

UC Denver Hemoph & Thrombo Ctr

Recruiting

Aurora, Colorado, United States, 80045

Indiana Hemophilia-Thromb Ctr

Recruiting

Indianapolis, Indiana, United States, 46260

University of Iowa_Iowa City

Recruiting

Iowa City, Iowa, United States, 52242

Penn State MS Hershey Med Ctr

Recruiting

Hershey, Pennsylvania, United States, 17033-2360

St Christopher Hosp for Child

Recruiting

Philadelphia, Pennsylvania, United States, 19134

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-10.