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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

NNC 0172-0000-2021 · 1 trial · 4 indications

Phase 1 1
NCT01228669Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or BCongenital Bleeding Disorder
COMPLETED52 Analytics
PHASE1COMPLETED
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Congenital Bleeding Disorder
NCT0122866952
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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 to 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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Frequently asked questions about NNC 0172-0000-2021

What is NNC 0172-0000-2021 used for?

NNC 0172-0000-2021 is an investigational small molecule being developed for congenital bleeding disorders, including haemophilia A and haemophilia B. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes NNC 0172-0000-2021?

NNC 0172-0000-2021 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is NNC 0172-0000-2021 in?

NNC 0172-0000-2021 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved for any use, and further clinical studies would be needed to establish its safety and efficacy.

What clinical trials is NNC 0172-0000-2021 in?

NNC 0172-0000-2021 has been studied in one completed Phase 1 clinical trial, identified as NCT01228669. This trial evaluated the safety of the drug in healthy male subjects and in subjects with haemophilia A or B, enrolling a total of 52 participants across multiple countries.

Is NNC 0172-0000-2021 the same as any other drug?

No alternative names for NNC 0172-0000-2021 have been disclosed. The drug is identified by this specific code name in clinical trial registries and is being developed by Novo Nordisk A/S for congenital bleeding disorders.