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NNC 0172-0000-2021

Phase 1

Congenital Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: May 15, 2019

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01228669Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or BPHASE1 COMPLETED 52 — — Oct 25, 2010Sep 10, 2012May 15, 201916 Austria, Denmark +9
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Study Endpoints
Primary Endpoints
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
from trial product administration until 43 days after trial product administration
Secondary Endpoints
Area under the concentration-time curve
from 43 days after trial product administration until 53 days after trial product administration
Adverse Events (AEs), including Serious Adverse Events (SAEs)
from 43 days after trial product administration until 53 days after trial product administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC 0172-0000-2021DRUGSingle dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
placeboDRUGSingle dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Body weight between 50 and 100 kg, both inclusive * Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive * For haemophilia subjects only: Diagnosed with severe haemophilia A or B Exclusion Criteria: * Known or suspected hypersensitivity to trial product(s)...

Countries:AustriaDenmarkGermanyItalyMalaysiaSouth AfricaSpainSwedenSwitzerlandThailandUnited Kingdom
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