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PT003

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |cbdMD, Inc.|Last Updated: Apr 27, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment185

FDA Designations

No designations recorded

Clinical trial landscape

PT003 · 1 trial · 1 indication

Phase 2 1
NCT01349816PT003 MDI Dose Confirmation StudyChronic Obstructive Pulmonary Disease
COMPLETED185 Analytics
PHASE2COMPLETED
PT003 MDI Dose Confirmation Study
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

FEV1 AUC0-12
Day 7

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).

Secondary Endpoints

Peak Change From Baseline in FEV1
Day 1
Time to Onset of Action
Day 1
At Least 12% Improvement in FEV1
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PT003 (Dose 1)EXPERIMENTALPT003 MDI Dose 1
PT003 (Dose 2)EXPERIMENTALPT003 MDI Dose 2
PT003 (Dose 3)EXPERIMENTALPT003 MDI Dose 3
PT003 (Dose 4)EXPERIMENTALPT003 MDI Dose 4
PT001EXPERIMENTALPT001 MDI
PT005EXPERIMENTALPT005 MDI

Interventions

NameTypeDescription
PT003DRUGPT003 MDI administered as two puffs BID for 7 days
PT001DRUGPT001 MDI administered as two puffs BID for 7 days
PT005DRUGPT005 MDI administered as two puffs BID for 7 days
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria: * Signed written informed consent * 40 - 80 years of age * Clinical history of COPD with airflow limitation that is not fully reversible * Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive ...

Countries:United States
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Frequently asked questions about PT003

What is PT003 used for in Chronic Obstructive Pulmonary Disease?

PT003 is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 2 clinical development and has completed one trial in this indication. The drug is being studied as a potential therapy for patients with COPD.

Who makes PT003?

PT003 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is advancing this investigational drug through clinical development for the treatment of Chronic Obstructive Pulmonary Disease.

What phase is PT003 in?

PT003 is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a dose confirmation study. The drug is investigational and has not yet been approved by regulatory authorities for the treatment of Chronic Obstructive Pulmonary Disease.

What clinical trials is PT003 in?

PT003 has been studied in one clinical trial, identified as NCT01349816, titled "PT003 MDI Dose Confirmation Study." This Phase 2 trial was completed and enrolled 185 participants with Chronic Obstructive Pulmonary Disease in the United States. The trial was randomized, double-blind, and controlled.

Is PT003 the same as any other drug?

PT003 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by cbdMD, Inc. for the treatment of Chronic Obstructive Pulmonary Disease and is currently in Phase 2 clinical development.