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Aerolized Hydroxychloroquine

Phase 1

Severe Acute Respiratory Syndrome Coronavirus 2 | Small molecule | Infectious Disease |cbdMD, Inc.|Last Updated: Oct 8, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Aerolized Hydroxychloroquine · 1 trial · 1 indication

Phase 1 1
NCT04461353A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult VolunteersSevere Acute Respiratory Syndrome Coronavirus 2
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
Severe Acute Respiratory Syndrome Coronavirus 2
NCT0446135312
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Study Endpoints

Primary Endpoints

Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0
after treatment (Day 1) through to Day 30

TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)

Change from baseline in clinical laboratory test results for CBC with differential
Screening and Day 8

Blood sample collected for CBC with differential will be assessed from baseline (at screening)

Incidence of abnormal laboratory test results for CBC with differential at Screening
Screening

Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests

Incidence of abnormal laboratory test results for CBC with differential - Day 8
Day 8

Day 8 blood sample collected for CBC with differential

Changes from baseline for blood glucose
Screening and Day 1

Blood sample collected for blood glucose and measured with a glucometer

Incidence of abnormal laboratory test results for chemistry -Screening
Screening

Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)

Incidence of abnormal laboratory tests results for chemistry - Day 8
Day 8

Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)

Incidence of abnormal laboratory tests results for urinalysis - Screening
Screening

Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood

Incidence of abnormal laboratory tests results for urinalysis- Day 8
Day 8

Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood

Changes in vital signs from baseline (pre-dose) - respiratory rate
Screening, Day 1, Day 2 and Day 8

The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)

Changes in vital signs from baseline (pre-dose)- temperature
Screening, Day 1, Day 2 and Day 8

Oral temperature

Changes in vital signs from baseline (pre-dose) - seated blood pressure
Screening, Day 1, Day 2 and Day 8

Systolic and diastolic blood pressure

Changes in vital signs from baseline (pre-dose) - pulse
Screening, Day 1, Day 2 and Day 8

Heart rate measure by radial pulse rate (beats/min)

Changes in vital signs from baseline (pre-dose) - O2 saturation
Screening, Day 1, Day 2 and Day 8

O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter \<92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)

Incidence of abnormal and physical examinations findings during Screening- general appearance
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - general appearance
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2- general appearance
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- general appearance
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening- neurological
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1- neurological
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2- neurological
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- neurological
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular
Day 1 (pre-dose, within 3 hours of dose)

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening - lungs
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - lungs
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2 - lungs
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8 - lungs
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening- abdomen
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - abdomen
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2- abdomen
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- abdomen
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during screening- endocrine
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - endocrine
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2- endocrine
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- endocrine
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening- extremities
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1- extremities
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2- extremities
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- extremities
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during Screening- lymphatic
Screening

Physical exam by clinician. A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1- lymphatic
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2 - lymphatic
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8- lymphatic
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings during screening - skin
Screening

A directed physical examination will be conducted

Incidence of abnormal and physical examinations findings on Day 1 - skin
Day 1

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 2 - skin
Day 2

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Incidence of abnormal and physical examinations findings on Day 8 - skin
Day 8

Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Changes from baseline for pulmonary function tests (PFTs) - FEV1
Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Pulmonary function testing and recording of FEV1, both actual and percent predicted

Changes from baseline for pulmonary function tests (PFTs) - FVC
Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Pulmonary function testing and recording of FVC, , both actual and percent predicted

Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC
creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Pulmonary function testing and recording of FEV1/FVC

Changes from baseline for ECG readings - QT interval
Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval (msec) will be the assessment parameter.

Changes from baseline for ECG readings - QTcB Interval
Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QTcB interval (msec) will be the assessment parameter.

Changes from baseline for ECG readings - QRS duration
Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QRS duration (msec) will be the assessment parameter.

Changes from baseline for ECG readings - PR interval
Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG PR interval (msec) will be the assessment parameter.

Changes from baseline for ECG readings - heart rate
Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG heart rate (beats/min) will be the assessment parameter.

Incidence of abnormal ECG - Screening
Screening

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Incidence of abnormal ECG- Day 1
Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hours

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Incidence of abnormal ECG - Day 2
Days 2

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Incidence of abnormal ECG - Day 8
Days 8.

The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Secondary Endpoints

HCQ concentration in whole blood versus time profiles
Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hydroxychloroquine SulfateACTIVE_COMPARATORThe study drug AHCQ will be administered by inhalation through the mouth. The starting dose will be 20 mg (Cohort A1) with a proposed subsequent dose of 50 mg (Cohort A2). At each dose level 8 participants (including at least 3 female participants and 3 participants older than 50 years old) will be enrolled. Six participants will receive the active study drug and 2 participants will receive placebo.
PlaceboPLACEBO_COMPARATORPlacebo will be administered by inhalation through the mouth. It will be administered in both Cohort A1 and Cohort A2. Six participants will receive the active study drug and 2 participants will receive placebo.

Interventions

NameTypeDescription
Aerolized Hydroxychloroquine SulfateDRUGsterile AHCQ 100 mg/mL for inhalation, is a clear solution packaged in clear glass vials and stored at room temperature.
PlaceboOTHERThe placebo product and diluent solution is sodium chloride inhalation solution, United States Pharmacopeia (USP) 0.9%.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Willing and able to give written informed consent. 2. Males or females aged ≥18 years old. 3. Good general health as determined by no acute illness and no clinically significant abnormal findings on medical history, vital signs, laboratory tests, or physical examination at sc...

Countries:United States
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Frequently asked questions about Aerolized Hydroxychloroquine

What is Aerolized Hydroxychloroquine used for?

Aerolized Hydroxychloroquine is an investigational small molecule being studied for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. It is formulated as an orally inhaled aerosol and is currently in Phase 1 clinical development.

Who makes Aerolized Hydroxychloroquine?

Aerolized Hydroxychloroquine is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The drug is in Phase 1 clinical development for the treatment of SARS-CoV-2 infection.

What phase is Aerolized Hydroxychloroquine in?

Aerolized Hydroxychloroquine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for SARS-CoV-2.

What clinical trials is Aerolized Hydroxychloroquine in?

Aerolized Hydroxychloroquine has one completed clinical trial, NCT04461353, titled 'A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' This Phase 1 trial enrolled 12 healthy adult participants in the United States.

Is Aerolized Hydroxychloroquine FDA approved?

Aerolized Hydroxychloroquine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for any use.