Recent Updates
Recently added Catalysts

NNC172-2021

Phase 1

Congenital Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: Feb 27, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01555749Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese SubjectsPHASE1 COMPLETED 8Mar 12, 2012May 8, 2012Feb 27, 20171 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
Week 5
Secondary Endpoints
Maximal concentration of NNC172-2021 (Cmax)
Week 5
Time point for maximal concentration (tmax)
Week 5
Terminal half-life (t1/2)
Week 5
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC172-2021 low dose / PlaceboEXPERIMENTAL -
NNC172-2021 high dose / PlaceboEXPERIMENTAL -
Interventions
NameTypeDescription
NNC172-2021DRUGOne injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
placeboDRUGOne injection administered subcutaneously (s.c., under the skin)
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent * Body weight between 50 and 100 kg, both inclusive * Body mass index (BMI) between 18.0 and 30.0 ...

Countries:United Kingdom
Unlock Eligibility Criteria