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NNC0114-0000-0005

Phase 1

Inflammation | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Feb 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

NNC0114-0000-0005 · 1 trial · 3 indications

Phase 1 1
NCT01208506First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid ArthritisInflammation
COMPLETED64 Analytics
PHASE1COMPLETED
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Inflammation
NCT0120850664
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Study Endpoints

Primary Endpoints

Incidence of adverse events
at least 12 weeks after dose administration

Secondary Endpoints

Area under the serum concentration-time curve
at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
at least 12 weeks after dose administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 1EXPERIMENTAL -
Dose level 2EXPERIMENTAL -
Dose level 3EXPERIMENTAL -
Dose level 4EXPERIMENTAL -
Dose level 5EXPERIMENTAL -
Dose level 6EXPERIMENTAL -
Dose level 7EXPERIMENTAL -
Dose level 8EXPERIMENTAL -

Interventions

NameTypeDescription
NNC0114-0000-0005DRUGA single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
placeboDRUGA single dose of NNC0114-0000-0005 placebo.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * For all subjects the following applies: * Male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. M...

Countries:Germany
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Frequently asked questions about NNC0114-0000-0005

What is NNC0114-0000-0005 used for?

NNC0114-0000-0005 is an investigational small molecule being developed for inflammation, specifically studied in rheumatoid arthritis. It is in Phase 1 clinical development and is not yet approved. The drug is being evaluated for its potential to treat inflammatory conditions.

Who makes NNC0114-0000-0005?

NNC0114-0000-0005 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 drug's safety and efficacy in inflammatory conditions.

What phase is NNC0114-0000-0005 in?

NNC0114-0000-0005 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is NNC0114-0000-0005 in?

NNC0114-0000-0005 has one completed clinical trial, identified as NCT01208506. This was a first-in-man study conducted in Germany, enrolling 64 participants, including healthy subjects and individuals with rheumatoid arthritis. The trial was randomized, double-blind, and controlled.

Is NNC0114-0000-0005 the same as NNC114-0005?

Yes, NNC0114-0000-0005 is also known as NNC114-0005. The clinical trial record for the drug uses the alternative name NNC114-0005 in its title. Both names refer to the same investigational small molecule being developed by Novo Nordisk.