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NNC 0141-0000-0100

Phase 1

Inflammation | Small molecule | Immunology |Innate Pharma S.A.|Last Updated: Dec 23, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

NNC 0141-0000-0100 · 1 trial · 2 indications

Phase 1 1
NCT01370902Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid ArthritisInflammation
COMPLETED92 Analytics
PHASE1COMPLETED
Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
Inflammation
NCT0137090292
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Study Endpoints

Primary Endpoints

Incidence of adverse events
from trial product administration to week 12

Secondary Endpoints

Antibodies against NNC141-0100
from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part
from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part
from trial product administration until final visit (week 12 or longer if applicable)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single-dose (SD) trial part (i.v.)EXPERIMENTAL -
Single-dose (SD) trial part (s.c.)EXPERIMENTAL -
Multiple-dose (MD) trial part (s.c.)EXPERIMENTAL -

Interventions

NameTypeDescription
NNC 0141-0000-0100DRUGSingle dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
placeboDRUGSingle dose administered subcutaneously (under the skin) as a comparator at all dose levels
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation * Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calcul...

Countries:Germany
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Frequently asked questions about NNC 0141-0000-0100

What is NNC 0141-0000-0100 used for?

NNC 0141-0000-0100 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. A completed trial evaluated its safety and tolerability in subjects with rheumatoid arthritis.

Who makes NNC 0141-0000-0100?

NNC 0141-0000-0100 is being developed by Innate Pharma S.A., a biopharmaceutical company. The company's stock is traded under the ticker IPHA. The drug is in Phase 1 clinical development for inflammation and rheumatoid arthritis.

What phase is NNC 0141-0000-0100 in?

NNC 0141-0000-0100 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for inflammation and rheumatoid arthritis.

What clinical trials is NNC 0141-0000-0100 in?

NNC 0141-0000-0100 has one completed clinical trial, NCT01370902, titled "Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis." This Phase 1 study enrolled 92 participants in Germany and was randomized, double-blind, and controlled.

Is NNC 0141-0000-0100 the same as NNC0141-0000-0100?

NNC 0141-0000-0100 and NNC0141-0000-0100 refer to the same investigational drug. The clinical trial NCT01370902 uses the name NNC0141-0000-0100, while the drug is also referred to as NNC 0141-0000-0100. Both names denote the same small molecule being developed for inflammation.