Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without factor VIII inhibitors - FRONTIER1

ovo Nordisk A/S0 sites94 target enrollmentJuly 9, 2020

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Single ascending dose (SAD) part:
•\- Male, aged 18\-45 years (both inclusive) at the time of signing informed consent
•\- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
•Multiple ascending dose (MAD) part:
•\- Male, aged 12\-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
•\- Diagnosis of congenital haemophilia A with FVIII activity \<1% based on medical records
•Exploratory biomarker cohort:
•\- Male, aged \=12 years at the time of signing informed consent (Germany and Japan have local requirements)
•\- Diagnosis of congenital haemophilia A with FVIII activity \<1% based on medical records
•Are the trial subjects under 18? no

•\- Factor VIII activity \=150% at screening
•\- 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
•\- Known congenital or acquired coagulation disorders other than haemophilia A
•\- Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter\-associated thrombosis for which anti\-thrombotic treatment is not currently ongoing
•\- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter\-associated thrombosis for which anti\-thrombotic treatment is not currently ongoing
•\- Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
•\- Any autoimmune disease that may increase the risk of thrombosis
•\- Receipt of emicizumab or drugs with similar modes of action within 5 half\-lives before trial product administration
•\- Ongoing or planned immune tolerance induction therapy