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NNC0442-0344 A

Phase 1

Haemophilia A | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Aug 10, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment205

FDA Designations

No designations recorded

Clinical trial landscape

NNC0442-0344 A · 3 trials · 1 indication

Phase 1 3
NCT07238816A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy PeopleHaemophilia A
COMPLETED80 Analytics
NCT07220564A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia AHaemophilia A
RECRUITING30 Analytics
NCT06649630A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy MenHaemophilia A
COMPLETED95 Analytics
PHASE1COMPLETED
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
Haemophilia A
NCT0723881680
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PHASE1RECRUITING
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Haemophilia A
NCT0722056430
Unlock trial analytics
PHASE1COMPLETED
A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men
Haemophilia A
NCT0664963095
Unlock trial analytics

Study Endpoints

Primary Endpoints

AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
From baseline (Day 1) to day 17

Measured as nanograms\*day per millilitre (ng\*day/mL).

Number of treatment emergent adverse events
From time of dosing (Day 1) to end of follow-up (Day 46)

Measured as count of events.

SAD: Number of treatment emergent adverse events
From time of dosing (Day 1) to Day 36

Measured as count of events.

MAD: Number of treatment emergent adverse events
From time of dosing (Day 1) to end of follow-up (Day 46)

Measured as count of events.

SSD: Number of treatment emergent adverse events
From time of dosing (Day 1) to Day 36

Measured as count of events.

Secondary Endpoints

Cmax: Maximum observed plasma Inno8 concentration after a single oral dose
From baseline (Day 1) to day 17
Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose
From baseline (Day 1) to day 17
Number of treatment emergent adverse events
From time of dosing (Day 1) to day 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Group BEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Group CEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Reference doseACTIVE_COMPARATORParticipants will receive oral dose of NNC0442-0344 A.
Cohort 1EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 2EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 3EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 1 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 2 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 3 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 4 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 5 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 1 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 2 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 3 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 4 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 1 (SSD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A subcutaneously.
Cohort 2 (SSD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A subcutaneously.
SAD: PlaceboPLACEBO_COMPARATORParticipants will receive single dose of placebo intravenously.
MAD: PlaceboPLACEBO_COMPARATORParticipants will receive a oral daily dose of Placebo for 10 days.
SSD: PlaceboPLACEBO_COMPARATORParticipants will receive single dose of placebo subcutaneously.

Interventions

NameTypeDescription
NNC0442-0344 ADRUGNNC0442-0344 A will be administered orally.
PlaceboDRUGSAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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) at screening. * Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening. * Cons...

Countries:United StatesAustriaBelgiumFranceGermanyItalyPolandPortugalSpainSwedenSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07220564lastUpdatePostDate: changed
LOWAug 11, 2026NCT07220564lastUpdatePostDate: changed
LOWAug 11, 2026NCT07220564lastUpdatePostDate: changed
MEDIUMJul 18, 2026NCT07238816TRIAL_REMOVED: changed
MEDIUMJul 18, 2026NCT07238816TRIAL_REMOVED: changed
MEDIUMJul 18, 2026NCT07238816TRIAL_REMOVED: changed
HIGHJun 18, 2026NCT07238816Status: RECRUITING → COMPLETED
HIGHJun 18, 2026NCT07238816Status: RECRUITING → COMPLETED
HIGHJun 18, 2026NCT07238816Status: RECRUITING → COMPLETED
HIGHJun 18, 2026NCT07238816Status: RECRUITING → COMPLETED

Frequently asked questions about NNC0442-0344 A

What is NNC0442-0344 A used for?

NNC0442-0344 A, also known as Inno8, is an investigational small molecule being developed for the treatment of haemophilia A. It is currently in Phase 1 clinical development, with studies evaluating its effects in healthy volunteers and in people with haemophilia A.

Who makes NNC0442-0344 A?

NNC0442-0344 A is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is in Phase 1 clinical development for haemophilia A.

What phase is NNC0442-0344 A in?

NNC0442-0344 A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and how it works in the body.

What clinical trials is NNC0442-0344 A in?

NNC0442-0344 A is being studied in three Phase 1 clinical trials. NCT06649630 and NCT07238816 have been completed, while NCT07220564 is currently recruiting. These trials evaluate different doses of the drug in healthy men and in men with haemophilia A.

Is NNC0442-0344 A the same as Inno8?

Yes, NNC0442-0344 A is also known as Inno8. Clinical trial records refer to the study medicine as Inno8, and it is being investigated for the treatment of haemophilia A.