This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
Unnamed facility
Berlin, Germany
Unnamed facility
Kitakyushu, Japan
Unnamed facility
Madrid, Spain
Frequency of Adverse Events (AEs)
Time frame: from first trial product administration until 12 weeks after last trial product administration
Frequency of serious adverse events (SAEs)
Time frame: from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)
Time frame: from first trial product administration until 12 weeks after last trial product administration
Neutralising antibodies against FVIIa and/or N7-GP
Time frame: from first trial product administration until 12 weeks after last trial product administration
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