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AIR645

Phase 1

Asthma | Small molecule | Respiratory |cbdMD, Inc.|Last Updated: Jun 25, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

AIR645 · 1 trial · 1 indication

Phase 1 1
NCT00658749A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled AsthmaAsthma
COMPLETED80 Analytics
PHASE1COMPLETED
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
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Study Endpoints

Primary Endpoints

Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests.
During dosing and for two weeks after dosing

Secondary Endpoints

Bioavailability
During dosing and for two weeks after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)
2PLACEBO_COMPARATORPhysiologic saline solution

Interventions

NameTypeDescription
AIR645DRUGAIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Physiologic saline solutionDRUGPlacebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria\*: * Good General Health (with or without allergic rhinitis and/or controlled asthma) * Non-smoker for at least 2 years * Normal lung function (DLCO) * Able to provide informed consent and to understand and comply with the requirements of the study Exclusion Criteria\*: * Clini...

Countries:United States
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Frequently asked questions about AIR645

What is AIR645 used for?

AIR645 is an investigational small molecule being developed for the treatment of asthma. It is a respiratory therapeutic that has completed a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

What does AIR645 target?

The molecular target of AIR645 has not been disclosed. The drug is a small molecule being studied for its effects in asthma, but its specific mechanism of action is not publicly available from the development data.

Who makes AIR645?

AIR645 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research on this investigational asthma treatment.

What phase is AIR645 in?

AIR645 is in Phase 1 clinical development. A Phase 1 study has been completed, but the drug remains investigational and has not received regulatory approval. Further clinical trials would be needed to advance its development.

What clinical trials is AIR645 in?

AIR645 has one completed clinical trial, NCT00658749, titled "A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma." This was a randomized, double-blind, placebo-controlled study with 80 participants in the United States.

Is AIR645 the same as any other drug?

No alternative names for AIR645 have been reported. The drug is identified solely by its code name AIR645 in clinical development records.