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AP09004

Phase 2

Parkinson's Disease | Small molecule | Neurology |Indaptus Therapeutics, Inc.|Last Updated: May 28, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

AP09004 · 1 trial · 1 indication

Phase 2 1
NCT00918177An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's DiseaseParkinson's Disease
COMPLETED72 Analytics
PHASE2COMPLETED
An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate blood level profiles and safety of the AP09004

Secondary Endpoints

Efficacy of AP09004 on motor scores in Parkinson's patients
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Early patientsEXPERIMENTAL -
Moderate PatientsEXPERIMENTAL -

Interventions

NameTypeDescription
AP09004DRUG -
Carbidopa/Levodopa, immediate releaseDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

* Subjects between the ages of 18 and 75 years of age inclusive; * For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per ...

Countries:Israel
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Frequently asked questions about AP09004

What is AP09004 used for in Parkinson's Disease?

AP09004 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 2 clinical development, with one completed trial evaluating its pharmacokinetics and pharmacodynamics in patients with the condition.

Who makes AP09004?

AP09004 is being developed by Indaptus Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INDP. The company is conducting clinical research on this investigational drug for Parkinson's Disease.

What phase is AP09004 in?

AP09004 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for Parkinson's Disease.

What clinical trials is AP09004 in?

AP09004 has one completed clinical trial, registered as NCT00918177, titled "An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease." This Phase 2 study enrolled 72 participants in Israel.

Is AP09004 FDA approved?

AP09004 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Parkinson's Disease. The drug has completed one clinical trial, but it has not yet received regulatory approval for any indication.

What is the mechanism of action of AP09004?

The specific molecular target or mechanism of action for AP09004 has not been disclosed in available clinical trial information. The drug is being studied as a small molecule for Parkinson's Disease, but its precise biological pathway is not publicly detailed.