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AN01

Phase 1

Healthy Volunteer | Small molecule | Other |cbdMD, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

AN01 · 1 trial · 2 indications

Phase 1 1
NCT07554365A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy ParticipantsHealthy Volunteer
COMPLETED25 Analytics
PHASE1COMPLETED
A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants
Healthy Volunteer
NCT0755436525
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Study Endpoints

Primary Endpoints

Incidence, severity, relationship to the investigational drug, and types of adverse events and serious adverse events
Day 1 - Day 14
Number of participants with abnormal clinically significant physical examination (PE) results following study drug administration
Day 1 - Day 14
Number of participants with abnormal clinically significant vital signs following study drug administration
Day 1 - Day 14
Number of participants with abnormal clinically significant clinical laboratory results following study drug administration
Day 1 - Day 14
Number of participants with abnormal clinically significant spirometry parameters following study drug administration
Day 1 - Day 6
Number of participants with abnormal clinically significant respiratory assessment findings following study drug administration
Day 1 - Day 6
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters following study drug administration
Day 1 - Day 14

Secondary Endpoints

PK parameter assessed by serum AN01 concentration at specified timepoints for area under curve (AUC)
Day 1 - Day 9
PK parameter assessed by serum AN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
Day 1 - Day 9
PK parameter assessed by serum AN01 concentration at specified timepoints for time to peak concentration (Tmax)
Day 1 - Day 9
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AN01EXPERIMENTALEscalating multiple doses of AN01
PlaceboPLACEBO_COMPARATOREscalating doses of matching placebo

Interventions

NameTypeDescription
AN01DRUGActive study drug
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adults ≥18 and ≤60 years (inclusive). 2. Body Mass Index (BMI) ≥18 and ≤32 kg/m2 (inclusive). 3. Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, spirometry, and electrocardiogram (ECG)...

Countries:Australia
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