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Clinical Trials/JPRN-jRCT2031200136
JPRN-jRCT2031200136
Active, not recruiting
Phase 1

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) - Frontier 1

Tsuchiyama Akio0 sites82 target enrollmentOctober 5, 2020
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Conditionssevere haemophilia A with or without FVIII inhibitors

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
severe haemophilia A with or without FVIII inhibitors
Sponsor
Tsuchiyama Akio
Enrollment
82
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Tsuchiyama Akio

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •\-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
  • •\-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

Outcomes

Primary Outcomes

Not specified

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EUCTR2019-000465-20-PLovo Nordisk A/S94