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J147

Phase 1

Alzheimer's Disease | Small molecule | Neurology |IQVIA Holdings, Inc.|Last Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

J147 · 1 trial · 1 indication

Phase 1 1
NCT03838185Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147Alzheimer's Disease
COMPLETED64 Analytics
PHASE1COMPLETED
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
from pre-dose to 7+/-2 days post dose

Nature, frequency and severity of adverse events

Number of subjects with abnormal electrocardiogram
from pre-dose to 7+/-2 days post dose

12-lead electrocardiogram measurement

Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panel
from pre-dose to 7+/-2 days post dose

Changes in standard serum chemistry measures will be assessed.

Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panel
from pre-dose to 7+/-2 days post dose

Changes in standard hematology measures will be assessed.

Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panel
from pre-dose to 7+/-2 days post dose

Changes in standard urinalysis measures will be assessed.

Number of patients exhibiting changes in standard Physical Examination results
from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Neurological Examination results
from pre-dose to 7+/-2 days post dose

Secondary Endpoints

Maximum plasma concentration (Cmax)
0-48 hours post dose
Time to Cmax (Tmax)
0-48 hours post dose
Area under the plasma concentration vs. time curve (AUC)
0-48 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study DrugEXPERIMENTALHealthy young male subjects will receive a single ascending oral dose of J147 following an overnight fast of at least 8 hours. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
PlaceboPLACEBO_COMPARATORSubjects will receive a single oral dose of placebo with 240 mL non-carbonated water in the morning following an overnight fast of at least 8 hours.

Interventions

NameTypeDescription
J147DRUGSingle oral dose of J147
PlaceboDRUGSingle oral dose of corn oil
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provide voluntarily agreement to participate in this study and signs an IRB/IEC-approved informed consent prior to performing any of the screening procedures * Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of signing the informed consent; OR, Hea...

Countries:United States
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Frequently asked questions about J147

What is J147 used for?

J147 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its potential to address this neurological condition.

What does J147 target?

J147 is a small molecule being studied for Alzheimer's Disease. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is in Phase 1 development, with the focus of current research on safety, tolerability, and pharmacokinetics.

Who makes J147?

J147 is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. IQVIA is conducting clinical research on this investigational drug for Alzheimer's Disease, with the drug currently in Phase 1 development.

What phase is J147 in?

J147 is in Phase 1 clinical development for Alzheimer's Disease. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in the early stages of clinical testing.

What clinical trials is J147 in?

J147 has one completed Phase 1 clinical trial registered under NCT03838185, titled "Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147." This trial enrolled 64 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is J147 the same as any other drug?

J147 is not known to have any alternative names. It is a distinct investigational small molecule being developed for Alzheimer's Disease. The drug is currently in Phase 1 clinical development, with its safety and tolerability being evaluated in clinical trials.