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NNC0114-0000-0005

Phase 1

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

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01208506First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid ArthritisPHASE1 COMPLETED 64 — — Sep 1, 2010Feb 1, 2012Feb 8, 20171 Germany
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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 — 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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