Inno8 Absorption Study

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Disqualifiers: Thrombosis, Coagulation disorders, Gastrointestinal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 17 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine called Inno8 to determine how food and drink affect its absorption in the stomach. Participants will follow different fasting periods before and after taking the medicine to measure absorption. The trial includes four groups, so experiences may vary. It is suitable for healthy males weighing between 60 and 100 kilograms. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medicine.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Inno8 has been tested in earlier studies to assess its safety. So far, participants seem to tolerate it well. Most people in these studies reported only mild side effects, such as headaches and nausea, which are common with many medications. Importantly, no serious medical issues have been directly linked to Inno8.

Since this study is in an early phase, the main goal is to understand how the body processes the drug. This phase usually involves close monitoring to ensure safety. If the treatment progresses to later stages, it will be because it has demonstrated a safe profile so far.

Why do researchers think this study treatment might be promising?

Researchers are excited about the Inno8 treatment because it introduces a novel approach to absorption in the body, which could enhance the effectiveness of the active ingredient, NNC0442-0344 A. Unlike standard treatments that might require more invasive delivery methods, Inno8 is administered orally, potentially making it more convenient and accessible for patients. This ease of administration, combined with the innovative absorption mechanism, holds promise for improved patient outcomes compared to existing options.

What evidence suggests that this trial's treatments could be effective?

Research shows that Inno8 is under study as a potential treatment for hemophilia A, a condition where blood doesn’t clot properly. Inno8 is a special type of molecule that can help replace or mimic a missing protein in the blood. Early findings suggest that different doses of Inno8, which participants in this trial will receive in various treatment arms, work well in the body and are generally safe for healthy people. These studies examine how the body absorbs and processes Inno8, especially when taken with food. While more research is needed, early results are promising for Inno8 as a treatment option. ^{1 2 3 4 5}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This study is for healthy individuals interested in how food intake influences the absorption of a new medication called Inno8. Participants will be assigned to one of four groups, each with different fasting requirements before and after taking the medicine. The trial duration is up to 9.5 weeks.

Inclusion Criteria

Body mass index between 18.5 and 29.9 kg/m^2 at screening

Considered to be generally healthy based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

I am male.

Exclusion Criteria

Factor VIII activity ≥ 150% at screening

I or my close family have had blood clots without a clear reason.

I have been diagnosed with or show signs of blood clotting issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of Inno8 after an overnight fast, with varying fasting periods before and after dosing depending on the group

17 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of plasma concentration and adverse events

36 days

What Are the Treatments Tested in This Trial?

Interventions

• Inno8

Trial Overview The trial investigates Inno8, focusing on its absorption in relation to food consumption. It's structured into four arms; participants fast overnight, take Inno8, then continue fasting as per their group's protocol.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Group II: Group B Experimental Treatment 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Group III: Group A Experimental Treatment 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Group IV: Reference dose Active Control 1 Intervention

Participants will receive oral dose of NNC0442-0344 A.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220564

A Research Study Looking at How Different Doses of ... 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 ...

2. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/bic2025/jan-astermark/documents/bic-2025-oral-factor.pdf

Oral factor VIII (FVIII) bispecific molecule for haemophilia A • The data on Inno8 was kindly provided by Novo Nordisk A/S,. Bagsværd, Denmark and discussed with Jacob Lund and. Damaris Bausch-Fluck.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06649630

NCT06649630 | A Study Looking at How Different Doses of ... 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 ...

4. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN7442-7582.html

A Study Looking at How Different Doses of Study Medicine ... 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 ...

5. trial.medpath.com trial.medpath.com/clinical-trial/d8508a2e99f4f6c0/nct07238816-innos8-meal-timing-pharmacokinetics-healthy-participants

A Research Study Looking at How Food Intake Affects Inno8 ... The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms.