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 (NN7769-4513)
- Conditions
- severe haemophilia A with or without FVIII inhibitors
- Registration Number
- JPRN-jRCT2031200136
- Lead Sponsor
- Tsuchiyama Akio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 82
SAD part: 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
MAD part: 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
Exploratory biomarker cohort: Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records
SAD part:
-Factor FVIII 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
MAD part:
-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
Exploratory biomarker cohort:
-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
-Ongoing or planned immune tolerance induction therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method