A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

Официальное название

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

Обзор

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.

Вмешательства

• Препарат NNC0442-0344 A
  NNC0442-0344 A will be administered orally.

Первичные конечные точки

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

Вторичные конечные точки (10)

• Change in D-dimer [Срок оценки: From time of dosing (Day 1) to end of follow-up (Day 46)]
• Change in prothrombin fragment 1 and 2 [Срок оценки: From time of dosing (Day 1) to end of follow-up (Day 46)]
• Change in fibrinogen [Срок оценки: From time of dosing (Day 1) to end of follow-up (Day 46)]
• Change in platelets [Срок оценки: From time of dosing (Day 1) to end of follow-up (Day 46)]
• Occurrence of anti-Inno8 antibodies [Срок оценки: From time of dosing (Day 1) to end of follow-up (Day 46)]
• Cmax: the maximum concentration of Inno8 after multiple doses [Срок оценки: From Day 10 to Day 11]
• Tmax: the time to Cmax after last multiple dose [Срок оценки: From day 10 to Day 11]
• Tmax: the time to Cmax after first dose [Срок оценки: From Day 1 to Day 2]
• AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses [Срок оценки: From Day 10 to Day 11]
• Maximum thrombin generation (peak height) [Срок оценки: From Day 10 to Day 11]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 6 центров

• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
• Uniwersyteckie Centrum Kliniczne — Gdansk
• Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Me — Katowice
• Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku — Lublin
• Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan
• Instytut Hematologii i Transfuzjologii — Warsaw

США · 5 центров

• UC Denver Hemoph & Thrombo Ctr — Aurora
• Indiana Hemophilia-Thromb Ctr — Indianapolis
• University of Iowa_Iowa City — Iowa City
• Penn State MS Hershey Med Ctr — Hershey
• St Christopher Hosp for Child — Philadelphia

Испания · 5 центров

• Hospital Vall d'Hebron — Barcelona
• Hospital Universitario La Paz — Madrid
• Hospital Regional Universitario de Málaga — Málaga
• Hospital Clinico Universitario de Salamanca — Salamanca
• Hospital La Fe - Hemostasia y Trombosis — Valencia

Германия · 3 центра

• Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain — Berlin
• Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie — Bonn
• Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie — Hanover

Великобритания · 3 центра

• Queen Elizabeth Hospital, Birmingham - Haemophilia — Birmingham
• Royal Free Hospital - Haemophilia — London
• Royal Hallamshire Hospital — Sheffield

Австрия · 2 центра

• Universitätsklinik für Innere Medizin V — Innsbruck
• AKH - Klin. Abt. f. Haematologie u. Haemostaseologie — Vienna

Италия · 2 центра

• AOU Careggi Firenze — Florence
• Azienda Ospedaliera Universitaria Federico II di Napoli — Naples

Португалия · 2 центра

• ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia — Porto
• ULS São João, E.P.E._H.São João_Imunohemoterapia — Porto

Швеция · 2 центра

• Skåne US - Koagulationsmottagning — Malmö
• KS Solna - Koagulationsmottagningen — Solna

Бельгия · 1 центр

• Cliniques universitaires Saint-Luc — Brussels

Франция · 1 центр

• HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique — Bron

Швейцария · 1 центр

• Zentrum für Labormedizin — Sankt Gallen

Идентификаторы

NCT: NCT07220564 · NN7442-8454 · U1111-1317-4366 · 2025-520490-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗