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Different doses of Inno8 for adults with haemophilia A.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A

Phase 1 Interventional Novo Nordisk A/S · NCT07220564

This trial will test different doses of the experimental medicine Inno8 in adults with haemophilia A to see if it is safe and how the body handles it.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years to 64 Years
SexMale
SponsorNovo Nordisk A/S Industry-sponsored
Locations33 sites (Aurora, Colorado and 32 other locations)
Trial IDNCT07220564 on ClinicalTrials.gov

What this trial studies

This Phase 1, multicenter study will administer varying doses of the investigational drug Inno8 to adult males with congenital haemophilia A and monitor safety and drug levels over about 11 weeks. Participants will attend scheduled clinic visits for blood sampling, vital signs, and adverse event monitoring. Eligible participants are males aged 18–64 with factor VIII activity ≤15% who meet weight and other health criteria. The study is sponsored by Novo Nordisk and conducted at three US haemophilia centers.

Who should consider this trial

Good fit: Men aged 18–64 who weigh at least 45 kg and have congenital haemophilia A with factor VIII activity ≤15% and who meet the study's medical and medication restrictions are ideal candidates.

Not a fit: People excluded by the criteria—such as individuals with BMI ≥30, other coagulation disorders, a history of thrombosis, ongoing immune tolerance therapy, recent prophylactic haemophilia treatment, or women (the study enrolls males only)—are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Inno8 could become a new safe treatment option to help manage bleeding in people with haemophilia A.

How similar studies have performed: Other factor-replacement products and novel haemophilia A therapies have shown benefit in clinical development, but Inno8 itself is a new investigational agent being tested in this Phase 1 setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Aurora, Colorado and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Haemophilia A
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.