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UCB-J

Phase 1

Healthy | Unknown | Neurology |Alkermes plc|Last Updated: Feb 20, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

UCB-J · 1 trial · 2 indications

Early Phase 1 1
NCT03577262A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic DensityHealthy
COMPLETED19 Analytics
EARLY_PHASE1COMPLETED
A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
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Study Endpoints

Primary Endpoints

Measure [11C]-UCB-J plasma radioactivity levels in plasma over time
Day 1 to 28
Measure concentration of radioactivity as a function of time according to pre-defined brain regions
Day 1 to 28
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Healthy subjects [11C]-UCB-JEXPERIMENTALNet dose of approximately 370 megabecquerel (MBq) of \[11C\]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
AD patients [11C]-UCB-JEXPERIMENTALNet dose of approximately 370 megabecquerel (MBq) of \[11C\]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28

Interventions

NameTypeDescription
[11C]-UCB-JOTHERIV radioligand given prior to and during positron emission tomography (PET) scan
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Eligibility Criteria

Age Range55 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: Group 1 * Healthy male or female age 55 - 75 years old, inclusive, at the time of informed consent. * Mini-mental state examination (MMSE) greater than or equal to 27. Group 2 * Adult males or females age 55 - 75 years old, inclusive, at the time of informed consent. * Confir...

Countries:Netherlands
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Frequently asked questions about UCB-J

What is UCB-J?

UCB-J is an investigational radioligand being studied for imaging synaptic density. It is currently in Phase 1 clinical development. The drug is being developed by Alkermes plc (ticker: ALKS).

What is UCB-J used for?

UCB-J is being studied for use in imaging synaptic density in the brain. It is intended for use in healthy individuals and those with Alzheimer's disease, as part of a non-therapeutic feasibility study.

Who makes UCB-J?

UCB-J is being developed by Alkermes plc, a biopharmaceutical company. Alkermes trades on the stock exchange under the ticker symbol ALKS.

What phase is UCB-J in?

UCB-J is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in an early Phase 1 trial.

What clinical trials is UCB-J in?

UCB-J has one completed clinical trial, NCT03577262, titled 'A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density'. This trial enrolled 19 participants and was conducted in the Netherlands.

Is UCB-J the same as [11C]-UCB-J?

Yes, UCB-J is also known as [11C]-UCB-J. The clinical trial NCT03577262 uses the name [11C]-UCB-J to refer to the radioligand being studied for imaging synaptic density.