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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001127493
Ethics application status
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Approved
Date submitted
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25/09/2025
Date registered
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15/10/2025
Date last updated
Help: Date last updated
2/07/2026
Date data sharing statement initially provided
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15/10/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of CBD Inhalation Aerosol in Healthy Adult Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of CBD Inhalation Aerosol in Healthy Adult Volunteers
Additional trial identifiers [1] 315452 0
IRX616-003
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Panic Disorder 339008 0
Condition category
Condition code
Mental Health 335298 335298 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study is a Phase 1, single ascending dose, randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of IRX616a (cannabidiol, CBD) administered via oral inhalation in healthy adult volunteers.
Participants will undergo a screening phase (Days -28 to -2) including medical history, physical examination, laboratory tests, ECG, spirometry, and suicidality assessment (C-SSRS) to confirm eligibility.
On Day 1, participants will be randomized to receive either IRX616a or placebo as a single dose delivered by a pressurised metered dose inhaler (pMDI). Doses will be administered to cohorts only after review of safety and pharmacokinetic data by the Safety Review Committee. All participants will remain in the clinical research unit for at least 24 hours post-dose for intensive safety monitoring and serial pharmacokinetic blood sampling (up to 18 samples). Details about dosages are kept private until the study results have been analysed.
Sentinel dosing: Each cohort will begin with 2 sentinel participants (1 receiving IRX616a and 1 receiving placebo). These sentinel participants will receive the same doses outlined for their cohort. The sentinel participants will be dosed first, and the remaining 6 participants in the cohort will only be dosed at least 48 hours later, contingent upon a review of the initial safety data.
Safety assessments will include adverse event monitoring, vital signs, ECGs, laboratory tests, physical examinations, and C-SSRS assessments.
A follow-up visit will occur on Day 8 to complete final safety evaluations.
Dosing will be supervised by trained clinical staff, with inhaler use training provided prior to administration and actuation counts verified for adherence.
Intervention code [1] 332066 0
Treatment: Drugs
Description of the comparator or control
Participants randomized to the placebo arm will receive a single dose of inhalation aerosol identical in appearance and administration method to the active intervention but without cannabidiol (CBD).
The placebo will be delivered via the same pressurised metered dose inhaler (pMDI) device, with the number of actuations matched to the active treatment cohort (3–7 actuations).
Administration will occur on Day 1 under direct supervision in the clinical research unit, with participants remaining under observation for 24 hours post-dose. All procedures, including serial pharmacokinetic blood sampling, vital signs, ECGs, laboratory tests, physical examinations, and suicidality assessments (C-SSRS), will be performed on the same schedule as the active arm.
A follow-up visit on Day 8 will complete final safety assessments.
Control group
Placebo

Outcomes
Primary outcome [1] 342884 0
To characterize plasma pharmacokinetics (PK) profiles of Cannabidiol Inhalation Aerosol (IRX616a)
Timepoint [1] 342884 0
pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 15, 30, and 45 minutes, and 1, 2, 3, 4, 8, and 24 hours post-dose
Secondary outcome [1] 452561 0
To evaluate the safety and tolerability of Cannabidiol Inhalation Aerosol (IRX616a) (composite outcome)
Timepoint [1] 452561 0
screening (Day -28 to -2), admission (Day -1), pre-dose on Day 1, post-dose on Day 1 at 30 minutes, 1, 2, 3, 4, 6, and 8 hours, 24 hours post-dose, and at the end-of-study visit on Day 8, with adverse events monitored continuously from randomization until study completion.

Eligibility
Key inclusion criteria
1. Male or female, non-smoker (no use of tobacco or nicotine products within 6 months prior to first dose), aged more than or equal to 18 and less than or equal to 65 years, with BMI more than 18.0 and less than 32.0 kg/m2 and body weight more than or equal to 50.0 kg at dosing.
2. Participant is judged by the Principal Investigator or delegate to be in generally good health on the basis of medical history, physical examination, or clinical laboratory results during the screening.
3. Pulse between 45 and 100 beats per minute (bpm) at screening (inclusive)
4. Seated systolic blood pressure (BP) between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
5. No known allergic reaction to cannabis products (including CBD, marijuana and hashish)
6. Within the range of clinical laboratory tests for hepatic (ALT, AST and total bilirubin within 1.5 x ULN) and renal (eGFR more than or equal to 60mL/min/1.73m2) functions
7. The participant is able to perform deep inhalations with forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) to be more than or equal to 80% of predicted value and FEV1/FVC ratio of more than 0.7 at screening.
a. Testing for any out-of-range values may be repeated at the discretion of the Investigator.
8. Must not be pregnant, planning pregnancy or be breastfeeding (non-lactating).
9. Female participants must have negative serum hCG pregnancy test at screening and negative urine dip-stick test at check-in.
10. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized at least 6 months prior to the first study drug administration) must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
a. Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
11. Females of non-childbearing potential must be:
a. Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the postmenopausal status by documented FSH level ?40 mIU/mL; or
b. Surgically sterile (complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation at least 3 months prior to the first study drug administration).
12. Male participants who are not vasectomized for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose:
a. Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
13. Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
14. Male and female participants must be willing not to donate sperm and ova respectively for 90 days after the last dose.
15. Willing and able to adhere to all study requirements, including willingness to remain in the study unit for the entire duration of the confinement period.
16. Participant has a good venous access bilaterally.
17. Able to understand the study procedures and provide signed and dated informed consent form (ICF) to participate in the study prior to screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or cardiovascular disease, Gilbert’s syndrome, or other condition which would jeopardize safety or impact validity of results (in the opinion the Principal Investigator or delegate);
2. Participant has any documented clinically significant infection, injury, or illness within 1 month prior to screening.
3. Participant has any documented history of, or currently active, seizure disorder or history of clinically significant head injury
4. Participant has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
5. Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
6. Known upper respiratory tract infection within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening, or any current or recent respiratory conditions, in the opinion the Investigator, might significantly alter the pharmacodynamic response to study drug.
7. History or presence of active lung disease (i.e. asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis) or prior intubation for respiratory illness.
8. History of active tuberculosis or presence of active or latent tuberculosis
9. History or presence of clinically significant psychiatric disorder or mental illness, as determined by the Investigator based on medical history, clinical interview, and/or relevant medical records. This includes but is not limited to schizophrenia spectrum disorders, bipolar disorder, major depressive disorder of moderate or greater severity within the past 2 years, or any current psychiatric condition that, in the Investigator’s opinion, could confound study results or pose additional risk to the participant. Past psychiatric conditions in sustained remission (e.g., a single moderate episode of major depressive disorder more than 2 years ago without recurrence) will not be exclusionary unless, in the Investigator’s judgment, there is a high likelihood of relapse during study participation.
10. History of inherent cardiac abnormalities based on the opinion of the Principal Investigator or delegate.
11. Clinically significant ECG abnormalities (Fridericia’s corrected QT interval [QTcF] more than 450 ms for males and more than 470 ms for females), PR more than 220 ms, QRS interval more than 120 ms at screening.
Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
12. Participant has any documented history of a medical condition that, in the opinion of the Investigator, would compromise the participant’s ability to inhale, absorb, metabolize, or excrete test product.
13. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Participants with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
14. A calculated creatinine clearance of less than 60 mL/minuteat Screening according to the equation using Cockcroft and Gault.
Testing for any out-of-range laboratory tests values may be repeated once at the discretion of the Investigator.
15. Positive urine drug screen, urine cotinine and alcohol breath test and at screening or check-in.
Testing may be repeated once at the discretion of the Investigator.
16. Known allergic reactions to any excipient in the formulations.
17. History of significant abuse of drugs such as marijuana, cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
18. Use of marijuana (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
19. History of alcohol abuse within 6 months prior to screening or excessive alcohol use within 6 months prior to screening. Excessive alcohol use is defined as regular consumption of more than 14 units of alcohol per week.
20. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption):
21. Prescription medications (except for hormonal contraceptives) within 14 days prior to the first dose until end of the study;
22. Monoamine oxidase inhibitors (MAOIs) within 28 days prior to dosing;
23. Over-the-counter products and natural health products (including herbal remedies such as St. John’s wort, homeopathic and traditional medicines), and antacid preparations within 14 days prior to the first dose up to end-of-study. Vitamins used as nutritional supplements in non-therapeutic doses (judged by the qualified Investigator or designee) may be accepted, but they must be stopped at least 48 hours before dosing and during the study.
24. Any drugs known to induce or inhibit hepatic and renal drug metabolism within 30 days prior to the first dose.
25. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or a minimum of 5 half-lives, whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days prior to the first dose, or concomitant participation in an investigational study involving no drug or device administration.
26. Donation of plasma or platelets within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 56 days prior to Day -1.
27. Any reason which, in the opinion of the Principal Investigator or delegate, would prevent the participant from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization with independent code management
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization schedule with a 3:1 allocation ratio (IRX616a:placebo) per cohort, including sentinel dosing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2025
Actual
26/02/2026
Date of last participant enrolment
Anticipated
1/12/2026
Actual
11/05/2026
Date of last data collection
Anticipated
9/12/2026
Actual
19/05/2026
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 320045 0
Commercial sector/Industry
Name [1] 320045 0
InhaleRx Ltd.
Country [1] 320045 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
InhaleRx Ltd.
Address
Country
Australia
Secondary sponsor category [1] 322592 0
None
Name [1] 322592 0
Address [1] 322592 0
Country [1] 322592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318587 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 318587 0
Ethics committee country [1] 318587 0
Australia
Date submitted for ethics approval [1] 318587 0
22/07/2025
Approval date [1] 318587 0
25/08/2025
Ethics approval number [1] 318587 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144634 0
Dr James Connell
Address 144634 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace Adelaide South Australia 5000
Country 144634 0
Australia
Phone 144634 0
+610413231264
Fax 144634 0
Email 144634 0
[email protected]
Contact person for public queries
Name 144635 0
Darryl Davies
Address 144635 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 144635 0
Australia
Phone 144635 0
+611300030380
Fax 144635 0
Email 144635 0
[email protected]
Contact person for scientific queries
Name 144636 0
Darryl Davies
Address 144636 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 144636 0
Australia
Phone 144636 0
+611300030380
Fax 144636 0
Email 144636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.