Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:
• 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.
Locations
United States
Colorado
UC Denver Hemoph & Thrombo Ctr
NOT_YET_RECRUITING
Aurora
Iowa
University of Iowa_Iowa City
RECRUITING
Iowa City
Indiana
Indiana Hemophilia-Thromb Ctr
RECRUITING
Indianapolis
Pennsylvania
Penn State MS Hershey Med Ctr
RECRUITING
Hershey
St Christopher Hosp for Child
NOT_YET_RECRUITING
Philadelphia
Other Locations
Austria
Universitätsklinik für Innere Medizin V
RECRUITING
Innsbruck
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
RECRUITING
Vienna
Belgium
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
France
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
NOT_YET_RECRUITING
Bron
Germany
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
RECRUITING
Berlin
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
NOT_YET_RECRUITING
Bonn
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
RECRUITING
Hanover
Italy
AOU Careggi Firenze
RECRUITING
Florence
Azienda Ospedaliera Universitaria Federico II di Napoli
RECRUITING
Naples
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Bialystok
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach
NOT_YET_RECRUITING
Katowice
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
NOT_YET_RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny W Poznaniu
NOT_YET_RECRUITING
Poznan
Instytut Hematologii i Transfuzjologii
RECRUITING
Warsaw
Portugal
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia
NOT_YET_RECRUITING
Porto
ULS São João, E.P.E._H.São João_Imunohemoterapia
NOT_YET_RECRUITING
Porto
Spain
Hospital Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital La Fe - Hemostasia y Trombosis
NOT_YET_RECRUITING
Valencia
Sweden
Skåne US - Koagulationsmottagning
NOT_YET_RECRUITING
Malmö
KS Solna - Koagulationsmottagningen
NOT_YET_RECRUITING
Solna
Switzerland
Zentrum für Labormedizin
NOT_YET_RECRUITING
Sankt Gallen
United Kingdom
Queen Elizabeth Hospital, Birmingham - Haemophilia
NOT_YET_RECRUITING
Birmingham
Royal Free Hospital - Haemophilia
RECRUITING
London
Royal Hallamshire Hospital
NOT_YET_RECRUITING
Sheffield
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2027-02-05
Participants
Target number of participants: 30
Treatments
Experimental: Cohort 1
Participants will receive oral dose of NNC0442-0344 A.
Experimental: Cohort 2
Participants will receive oral dose of NNC0442-0344 A.
Experimental: Cohort 3
Participants will receive oral dose of NNC0442-0344 A.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S