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NNC 0128-0000-2011

Phase 1

Congenital Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: May 13, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01272206Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male SubjectsPHASE1 COMPLETED 12 — — Jan 1, 2011Mar 1, 2011Aug 20, 20141 United Kingdom
NCT01288391Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B PatientsPHASE1 COMPLETED 15 — — Jan 1, 2011Jul 1, 2011May 13, 20163 Germany, Japan +1
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Study Endpoints
Primary Endpoints
Frequency of adverse events (AEs)
from first trial product administration until maximally 10 weeks after last trial product administration
Frequency of serious adverse events (SAEs)
from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)
from first trial product administration until 12 weeks after last trial product administration
Secondary Endpoints
Neutralising antibodies against FVII and/or N7-GP
from first trial product administration until maximally 10 weeks after last trial product administration
Neutralising antibodies against FVIIa and/or N7-GP
from first trial product administration until 12 weeks after last trial product administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
100 mcg/kgEXPERIMENTAL -
200 mcg/kgEXPERIMENTAL -
Interventions
NameTypeDescription
NNC 0128-0000-2011DRUGAdministered as one single i.v. (intravenous) injection, 100 mcg/kg
NNC 0128-0000-2021DRUGAdministered as one single i.v. (intravenous) injection, 100 mcg/kg
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Eligibility Criteria
Age Range18 Years — 49 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Body weight between 50.0 and 100.0 kg, both inclusive * Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive Exclusion Criteria: * Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII * Any clinical s...

Countries:United KingdomGermanyJapanSpain
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