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NNC172-2021

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

NNC172-2021 · 1 trial · 4 indications

Phase 1 1
NCT01555749Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese SubjectsCongenital Bleeding Disorder
COMPLETED8 Analytics
PHASE1COMPLETED
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
Congenital Bleeding DisorderUnlock trial analytics

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
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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)
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Eligibility Criteria

Age Range20 Years to 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
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Frequently asked questions about NNC172-2021

What is NNC172-2021 used for?

NNC172-2021 is an investigational small molecule being developed by Novo Nordisk for congenital bleeding disorders, including haemophilia A and haemophilia B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing NNC172-2021?

NNC172-2021 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is in Phase 1 clinical development for congenital bleeding disorders.

What phase is NNC172-2021 in?

NNC172-2021 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this asset.

What clinical trials is NNC172-2021 in?

NNC172-2021 has one completed Phase 1 clinical trial, NCT01555749, which investigated the pharmacokinetics of the drug at two dose levels in healthy Japanese subjects. The trial enrolled 8 male participants and was conducted in the United Kingdom.

Is NNC172-2021 the same as any other drug?

No alternative names for NNC172-2021 have been identified. The drug is referred to solely by its development code NNC172-2021 in clinical trial records.