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PXT002331

Phase 1

Parkinson's Disease | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Sep 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

PXT002331 · 1 trial · 1 indication

Phase 1 1
NCT02639221A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female SubjectsParkinson's Disease
COMPLETED64 Analytics
PHASE1COMPLETED
A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Serious Adverse Events
16 days
Number of clinically relevant signs or symptoms
16 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
PXT002331EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PXT002331DRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects will be; 1.1. males or females of non childbearing potential 1.2. For females, non childbearing potential is defined as follows: * permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal...

Countries:United Kingdom
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Frequently asked questions about PXT002331

What is PXT002331 used for in Parkinson's Disease?

PXT002331 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under study to evaluate its safety, tolerability, and pharmacokinetics in humans.

Who makes PXT002331?

PXT002331 is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD on the stock market. The company is conducting clinical research to evaluate this investigational drug candidate for Parkinson's Disease.

What phase is PXT002331 in?

PXT002331 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was a first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. The drug remains investigational and is not yet approved for any use.

What clinical trials is PXT002331 in?

PXT002331 has one completed clinical trial registered under NCT02639221. This was a Phase 1, double-blind, placebo-controlled, first-in-human study with single and multiple ascending oral doses, conducted in the United Kingdom with 64 healthy male and female subjects aged 18 years and older.

How does PXT002331 work?

The specific molecular target of PXT002331 has not been disclosed in available clinical trial information. As a small molecule being studied for Parkinson's Disease, its mechanism of action is not publicly detailed, and further research is needed to understand how it may exert potential therapeutic effects.