A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT07220564
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Haemophilia A
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Accepted
Interventions
- NNC0442-0344 A — DRUGNNC0442-0344 A will be administered orally.
Study Details
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.
Key Dates
- Start date
- Oct 23, 2025
- Status verified
- Apr 2026
- Primary completion
- Feb 5, 2027
- Completion
- Feb 5, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1Participants will receive oral dose of NNC0442-0344 A.
- Experimental: Cohort 2Participants will receive oral dose of NNC0442-0344 A.
- Experimental: Cohort 3Participants will receive oral dose of NNC0442-0344 A.
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
- Novo Nordisk(+1) 866-867-7178
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Denver Hemoph & Thrombo Ctr | Aurora | Colorado | 80045 | - |
| Indiana Hemophilia-Thromb Ctr | Indianapolis | Indiana | 46260 | - |
| University of Iowa_Iowa City | Iowa City | Iowa | 52242 | - |
| Penn State MS Hershey Med Ctr | Hershey | Pennsylvania | 17033-2360 | - |
| St Christopher Hosp for Child | Philadelphia | Pennsylvania | 19134 | - |
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