Healthy VolunteersPhase 1NCT06019065
A SAD, MAD and Food Effect Study to Evaluate the Safety, Tolerability, PK, and PD of AJA001 in Healthy Subjects
A Phase 1 study testing AJA001 in people with Healthy Volunteers, run by AJNA Australia Pty Ltd at 1 site in Australia.
Trial summary
This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants. Food effect will be evaluated in one cross-over SAD fed dose cohort. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AJA001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Sep 2023to 15 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide signed ethics committee (EC)-approved consent form prior to any study procedures, can understand and comply with the requirements of the study, and are able to communicate with the Investigator
- Males and females, aged 18 and 65 years (inclusive), with body mass index (BMI) of 18 32.0 kg/m2 and body weight ≥50.0 kg at screening
- No known allergic reaction to cannabis products and formulation components (Glyceryl Monolinoleate, NF and organic chocolate mint flavoring agent)
- Medically healthy with no clinically significant medical history (fully resolved childhood asthma and mild asthma that does not require a reliever more than once per month, and does not require a preventer or any additional therapies is not considered clinically significant and permissible), physical examination, laboratory profiles, vital signs, or ECG, as deemed by the Investigator
- Must have hepatic and renal clinical laboratory test results (ALT, AST, total bilirubin [including direct and indirect bilirubin results], and eGFR) within a laboratory defined normal range
- Male participants who are not vasectomized for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the acceptable contraceptive methods specified below under "Contraception" in Section 8.1 from the first dose and for 90 days after the last dose
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- 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 acceptable contraceptive methods specified below specified below under "Contraception" throughout the study and for at least 3 months after the last study drug administration
- Refrain from donating sperm for the duration of the study and for at least 90 days after the last dose of investigational product (IP)
- Females must have a negative serum pregnancy test (SPT) at screening and urinary pregnancy test (UPT) at check-in on Day -1
- Agree to frequent blood sampling during the course of the study and with adequate venous access
- Agree to be confined for parts of the study in the Phase 1 unit and follow study procedures
- Agree to comply with the study-specified diet while confined in the Phase 1 unit. Participants in the Part A - cohort which enter the fed cross-over design (A-X) must agree to complete consumption of a standardized high-fat breakfast during the fed period on Day 15
- Negative drug and alcohol tests at screening and at admissions on Day -1 and willing to abstain from alcohol/illegal drug use from the screening visit until the End of Study (EOS) visit
- Able to read, understand, provide signed informed consent, communicate adequately, and comply with the requirements for the entire study.
Who cannot join
- Use of any medications or over the-counter (OTC) products within 10 days or 5 half lives (whichever is longer) prior to administration of study medication (including analgesics [note: except paracetamol up to 2 g per day], antibiotics, hormonal contraceptives* [except, which is permitted], natural food supplements, vitamins, garlic as a supplement)
- Note: Stable doses of oral contraceptives for birth control in women of childbearing potential (WOCBP) (minimum of 3 months without issue as deemed by the Investigator) will be allowed. No other hormonal treatment will be allowed.
- Use of an investigational drug or participation in an investigational study within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing
- Use of known inhibitors or inducers of hepatic drug metabolism (e.g., rifampin, carbamazepine, phenytoin, norethindrone, barbiturates [e.g., phenobarbital], dexamethasone, antidepressants [e.g., fluoxetine, paroxetine], proton pump inhibitors, ketoconazole) 1 month before the start of the study (Day 1)
- Hypersensitivity or any significant allergic reaction to the investigational compound/compound class being used in this study or any ingredients of this medication
- Medical history or any clinically significant disorder (as determined by the Investigator and Sponsor) including but not limited to: clinically significant allergies, asthma (fully resolved childhood asthma with no reoccurrences in adulthood is permissible), angioedema, pulmonary, bronchospasm, ulcer disease, gastrointestinal (GI), GI bleeding, coagulation defects, hypertension, edema, heart failure, hypokalemia, cardiovascular disease, significant dermatologic diseases or conditions; hematological, neurological, psychiatric, hepatic, or renal disorders; condition that would significantly influence the immune response; or history of infections of unexplained frequency or severity;
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- Personal diagnosis or first-degree relative diagnosis of psychosis/schizophrenia
- Presence of current psychiatric condition, suicide ideations or psychiatric condition requiring pharmacological management within the last 6 months
- History or presence of any condition that, in the opinion of the Investigator, could interfere with the study conduct or observation (to be confirmed by medical history)
- Has used any tobacco / nicotine-containing products (e.g., cigarettes, vaporizers, cigars, pipe tobacco, smokeless tobacco, nicotine gum, lozenges, patches) on more than 5 occasions within 1 month of the Screening visit
- History of significant drug abuse within 1 year prior to screening or use of drugs such as cannabis within 2 months prior to the screening visit or drugs such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
- History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week for female participants and 21 units for male participants (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
- History of or risk for seizures (one-off febrile seizure as a child is permissible)
- History or positive screening results to hepatitis B surface antigen or C virus Ab tests, or to human immunodeficiency virus (HIV) Ag/Ab combination, or has known immune deficiency disease at screening
- Surgical (history of stomach or intestinal surgery or resection) or medical condition (evidence of prior chronic GI disease such a cholecystitis, cholecystectomy, Gilbert's syndrome) that would interfere with gastric motility, pH, or absorption of study drug
- Laboratory values outside normal ranges based on the laboratory reference values and are clinically significant or ≥ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE; v5.0) (repeat testing is allowed once) at screening and Day -1
- Presence of out-of-range cardiac interval (PR ≥120 msec, PR ≤220 msec, QRSD <120 msec and QTcF ≤450 msec for males and females) on the ECG at screening and Day -1 or other clinically significant ECG abnormalities, unless deemed non significant by the Investigator
- Presence of clinically significant vital sign abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm, or RR less than 10 or over 22 resp/min) at screening and Day -1.
- Use of Δ9-tetrahydrocannabinol (THC)- or cannabidiol (CBD)-containing products within 60 days of start of study (Day 1)
- Serious illness in the 30 days preceding the beginning of treatment on Day 1 (i.e., that resulted in hospitalization)
- Receipt of treatment for any type of internal cancer within the 5 years prior to enrollment (fully treated and resolved basal cell carcinoma and or squamous cell carcinoma are permissible)
- Females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child
- Positive alcohol breath test or urine drug screen at screening or at admissions on Day -1
- Blood or plasma donation (500 mL) within the past month, or receipt of blood transfusion within 1 month prior to Day 1
- Employee, family member, or student of the Investigator or clinical site(s)
- Contraception:
- Male participants who are not vasectomized for at least 6 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:
- Simultaneous use of condom and established use of oral, injected or implanted hormonal contraceptive (at least 4 weeks prior to screening)
- Simultaneous use of condom and placement of intrauterine device (IUD) or intrauterine system (IUS)
- There are no contraceptive requirements if any of following conditions apply:
- Sexual partner is surgically sterile;
- Partner of non-childbearing potential;
- Same sex relationship;
- Abstinence from heterosexual intercourse as usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised 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:
- Simultaneous use of intrauterine contraceptive device without hormone release system placed at least 4 weeks prior to the first study drug administration; or intrauterine contraceptive device with hormone release system placed at least 12 weeks prior to first study drug administration; or oral hormonal contraceptives (minimum 12 week use without issue), and a condom for the male partner.
- Females of non-childbearing potential must be:
- Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level ≥40 mIU/mL; or
- Surgically sterile (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration).
- Please note women with tubal ligation will be required to undergo a pregnancy tests and partner to use a condom (ie. they will be treated as WOCBP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001 in Fasting and Fed Healthy Participants
This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants. Food effect will be evaluated in one cross-over SAD fed dose cohort.
Read the detailed description
The study is comprised of two parts, Part A (SAD) and Part B (MAD). Participants will be randomized (active or placebo) in each cohort of Parts A and B. Participants in Part A will receive a single dose of AJA001 or placebo on Day 1. Part A will include a fed-cohort (A-X) for one cohort where the participants will return to the clinical site on Day 14 to receive AJA001 or placebo. Participants in Part B will receive a split dose of AJA001 or placebo, where one dose will be administered as two equal doses taken twice daily, (BID; administered approximately every 12 hours [± 30 minutes]) for 6 consecutive days (Day 1-Day 6), and 1 morning dose on Day 7.
- Conditions
- Healthy Volunteers
- Being tested
- AJA001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJA001Drug
AJA001
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Single ascending dose of AJA001 | Experimental | AJA001 active q.d. 2.2 mL oral dose level 1 Receives: Drug: AJA001 |
| Cohort A1: Single ascending dose of placebo | Placebo comparator | AJA001 placebo q.d. 2.2 mL oral dose level 1 Receives: Other: Placebo |
| Cohort A2: Single ascending dose of AJA001 | Experimental | AJA001 active q.d. ascending oral dose level 2 Receives: Drug: AJA001 |
| Cohort A2: Single ascending dose of placebo | Placebo comparator | AJA001 placebo q.d. ascending oral dose level 2 Receives: Other: Placebo |
| Cohort A3: Single ascending dose of AJA001 | Experimental | AJA001 active q.d. ascending oral dose level 3 Receives: Drug: AJA001 |
| Cohort A3: Single ascending dose of placebo | Placebo comparator | AJA001 placebo q.d. ascending oral dose level 3 Receives: Other: Placebo |
| Cohort A4: Single ascending dose of AJA001 | Experimental | AJA001 active q.d. ascending oral dose level 4 Receives: Drug: AJA001 |
| Cohort A4: Single ascending dose of placebo | Placebo comparator | AJA001 placebo q.d. ascending oral dose level 4 Receives: Other: Placebo |
| Cohort B1: Multiple ascending doses of AJA001 | Experimental | AJA001 active b.i.d. oral dose level 1 Receives: Drug: AJA001 |
| Cohort B1: Multiple ascending doses of placebo | Placebo comparator | AJA001 placebo b.i.d. oral dose level 1 Receives: Other: Placebo |
| Cohort B2: Multiple ascending doses of AJA001 | Experimental | AJA001 active b.i.d. oral dose level 2 Receives: Drug: AJA001 |
| Cohort B2: Multiple ascending doses of placebo | Placebo comparator | AJA001 placebo b.i.d. oral dose level 2 Receives: Other: Placebo |
| Cohort B3: Multiple ascending doses of AJA001 | Experimental | AJA001 active b.i.d. oral dose level 3 Receives: Drug: AJA001 |
| Cohort B3: Multiple ascending doses of placebo | Placebo comparator | AJA001 placebo b.i.d. oral dose level 3 Receives: Other: Placebo |
| Cohort B4: Multiple ascending doses of AJA001 | Experimental | AJA001 active b.i.d. oral dose level 4 Receives: Drug: AJA001 |
| Cohort B4: Multiple ascending doses of placebo | Placebo comparator | AJA001 placebo b.i.d. oral dose level 4 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, severity and relationship of Adverse events (AEs)
Measured: Up to 21 days
Serious Adverse Events
Incidence of Serious adverse events (SAEs)
Measured: Up to 21 days
Adverse Events of Special Interest
Incidence of AEs of special interest (AESI), including abnormal clinically significant liver function test values (aspartate aminotransferase, alanine aminotransferase, total bilirubin and estimated glomerular filtration rate) due to major active pharmaceutical ingredient
Measured: Up to 21 days
Changes from baseline in hematology
Number of participants with changes from baseline in hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, reticulocyte count, white blood cell count, and differential white blood cell count
Measured: Up to 21 days
Changes from baseline in serum chemistry
Number of participants with changes from baseline in aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, sodium, potassium, chloride, calcium, magnesium, phosphorus, glucose, serum urea, uric acid, total bilirubin, creatinine, total protein, albumin, total cholesterol, triglycerides, creatinine phosphokinase, and follicle-stimulating hormone
Measured: Up to 21 days
Changes from baseline in urinalysis
Number of participants with changes from baseline in microscopic examination, specific gravity, pH, protein, glucose, ketones, blood, urobilinogen, bilirubin, nitrites, leucocytes, immunoassay for THC
Measured: Up to 21 days
Changes from baseline in blood pressure
Number of participants with changes from baseline in systolic and diastolic blood pressure in mm Hg
Measured: Up to 21 days
Changes from baseline in heart rate
Number of participants with changes from baseline in pulse rate (beats/minute)
Measured: Up to 21 days
Changes from baseline in respiratory rate
Number of participants with changes from baseline in respiratory rate (breaths/minute)
Measured: Up to 21 days
Changes from baseline in body temperature
Number of participants with changes from baseline in body temperature (tympanic; °C)
Measured: Up to 21 days
Changes from baseline in ECG recording of heart rate
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of heart rate in beats/minute
Measured: Up to 21 days
Changes from baseline in ECG recording of PR interval
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of PR interval in msec
Measured: Up to 21 days
Changes from baseline in ECG recording of RR interval
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of RR interval in msec
Measured: Up to 21 days
Changes from baseline in ECG recording of QRS duration
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of QRS duration in msec
Measured: Up to 21 days
Changes from baseline in ECG recording of QT interval
12-lead electrocardiogram (ECG) recordings of QT interval in msec
Measured: Up to 21 days
Changes from baseline in ECG recording of QTcF
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of QTcF in msec
Measured: Up to 21 days
Clinically significant physical examination findings
Number of participants with changes in the following parameters assessed during physical exams: general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes and nervous system
Measured: Up to 21 days
Changes in suicidal ideation and behavior
Number of participants with changes in Columbia Suicide Severity Rating Scale evaluation of suicidal ideation (yes/no), intensity of ideation (1-5 with 1 being the least severe and 5 being the most severe), and suicidal behavior (yes/no; if yes, include the number of attempts)
Measured: Up to 21 days
Use of concomitant medications
All medications taken after the first dose of the study drug and through the EOS visit will be considered a concomitant medication
Measured: Up to 21 days
Secondary outcomes (17)
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Cmin
Minimum observed plasma concentration (Cmin)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Cmax
Maximum observed plasma concentration (Cmax)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Tmax
Time of maximum serum concentration (Tmax)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: AUC0-last
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-last)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: AUC0-inf
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) [including percent of area under the curve obtained by extrapolation (AUCExtrap)]
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: lz
Terminal rate constant (lz)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: t1/2
Half-life (t1/2)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: Cl/F
Apparent clearance (Cl/F)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: Vz/F
Apparent volume of distribution (Vz/F)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: CTlast
Concentration at last time point (CTlast)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: AUC0-tau
Area under the concentration-time curve from time zero to the end of the dosing interval (tau) at steady state (AUC0-tau)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Vd/F,ss
Apparent volume of distribution at steady state (Vd/F,ss)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Cl/F,ss
Apparent clearance at steady state (Cl/F,ss)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Aer
Cumulative amount excrete renally (Aer)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: fe%
Fraction of unchanged drug excreted (fe%)
Measured: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: CLr [Ae0-t/AUC0-t]
Renal clearance (CLr [Ae0-t/AUC0-t])
Measured: Up to 21 days
Change from baseline in subjective pharmacodynamic effects
Assessed using the Drug Effects Questionnaire, a validated instrument commonly used in psychoactive drug research consisting of 20 items that are each rated using a unipolar 100 mm visual analog scale, with anchors of "not at all" on one end and "extremely" on the other. Participants are instructed to rate how they were feeling "right now" on six items related to the investigational study product: feeling the effect, liking any of the effects, disliking any of the effects, feeling any good effects, feeling any bad effects and likelihood of taking the study product again. Additionally, participants rate how much they are experiencing the following 14 adjectives: "sick," "heart racing," "anxious," "relaxed," "paranoid," "tired/drowsy," "alert," "irritable," "energetic," "restless," "hungry," "dazed," "distracted" and "euphoric/happy."
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start13 Sep 2023
- Primary completion26 Mar 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJNA Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, MD, Principal investigator, Q-Pharm Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019065
- Sponsor's protocol ID
- AJA001-001
- Status last verified
- Jul 2024
- First submitted
- 11 Aug 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001 in Fasting and Fed Healthy Participants
- ClinicalTrials.gov ID
- NCT06019065
- Acronym / sponsor ID
- AJA001-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AJNA Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants. Food effect will be evaluated in one cross-over SAD fed dose cohort.
Detailed description
The study is comprised of two parts, Part A (SAD) and Part B (MAD). Participants will be randomized (active or placebo) in each cohort of Parts A and B. Participants in Part A will receive a single dose of AJA001 or placebo on Day 1. Part A will include a fed-cohort (A-X) for one cohort where the participants will return to the clinical site on Day 14 to receive AJA001 or placebo. Participants in Part B will receive a split dose of AJA001 or placebo, where one dose will be administered as two equal doses taken twice daily, (BID; administered approximately every 12 hours [± 30 minutes]) for 6 consecutive days (Day 1-Day 6), and 1 morning dose on Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Single ascending dose of AJA001 | Experimental | Drug: AJA001AJA001 active q.d. 2.2 mL oral dose level 1 |
| Cohort A1: Single ascending dose of placebo | Placebo comparator | Other: PlaceboAJA001 placebo q.d. 2.2 mL oral dose level 1 |
| Cohort A2: Single ascending dose of AJA001 | Experimental | Drug: AJA001AJA001 active q.d. ascending oral dose level 2 |
| Cohort A2: Single ascending dose of placebo | Placebo comparator | Other: PlaceboAJA001 placebo q.d. ascending oral dose level 2 |
| Cohort A3: Single ascending dose of AJA001 | Experimental | Drug: AJA001AJA001 active q.d. ascending oral dose level 3 |
| Cohort A3: Single ascending dose of placebo | Placebo comparator | Other: PlaceboAJA001 placebo q.d. ascending oral dose level 3 |
| Cohort A4: Single ascending dose of AJA001 | Experimental | Drug: AJA001AJA001 active q.d. ascending oral dose level 4 |
| Cohort A4: Single ascending dose of placebo | Placebo comparator | Other: PlaceboAJA001 placebo q.d. ascending oral dose level 4 |
| Cohort B1: Multiple ascending doses of AJA001 | Experimental | Drug: AJA001AJA001 active b.i.d. oral dose level 1 |
| Cohort B1: Multiple ascending doses of placebo | Placebo comparator | Other: PlaceboAJA001 placebo b.i.d. oral dose level 1 |
| Cohort B2: Multiple ascending doses of AJA001 | Experimental | Drug: AJA001AJA001 active b.i.d. oral dose level 2 |
| Cohort B2: Multiple ascending doses of placebo | Placebo comparator | Other: PlaceboAJA001 placebo b.i.d. oral dose level 2 |
| Cohort B3: Multiple ascending doses of AJA001 | Experimental | Drug: AJA001AJA001 active b.i.d. oral dose level 3 |
| Cohort B3: Multiple ascending doses of placebo | Placebo comparator | Other: PlaceboAJA001 placebo b.i.d. oral dose level 3 |
| Cohort B4: Multiple ascending doses of AJA001 | Experimental | Drug: AJA001AJA001 active b.i.d. oral dose level 4 |
| Cohort B4: Multiple ascending doses of placebo | Placebo comparator | Other: PlaceboAJA001 placebo b.i.d. oral dose level 4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provide signed ethics committee (EC)-approved consent form prior to any study procedures, can understand and comply with the requirements of the study, and are able to communicate with the Investigator
- Males and females, aged 18 and 65 years (inclusive), with body mass index (BMI) of 18 32.0 kg/m2 and body weight ≥50.0 kg at screening
- No known allergic reaction to cannabis products and formulation components (Glyceryl Monolinoleate, NF and organic chocolate mint flavoring agent)
- Medically healthy with no clinically significant medical history (fully resolved childhood asthma and mild asthma that does not require a reliever more than once per month, and does not require a preventer or any additional therapies is not considered clinically significant and permissible), physical examination, laboratory profiles, vital signs, or ECG, as deemed by the Investigator
- Must have hepatic and renal clinical laboratory test results (ALT, AST, total bilirubin [including direct and indirect bilirubin results], and eGFR) within a laboratory defined normal range
Key exclusion criteria (40 listed)
- Use of any medications or over the-counter (OTC) products within 10 days or 5 half lives (whichever is longer) prior to administration of study medication (including analgesics [note: except paracetamol up to 2 g per day], antibiotics, hormonal contraceptives* [except, which is permitted], natural food supplements, vitamins, garlic as a supplement)
- Note: Stable doses of oral contraceptives for birth control in women of childbearing potential (WOCBP) (minimum of 3 months without issue as deemed by the Investigator) will be allowed. No other hormonal treatment will be allowed.
- Use of an investigational drug or participation in an investigational study within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing
- Use of known inhibitors or inducers of hepatic drug metabolism (e.g., rifampin, carbamazepine, phenytoin, norethindrone, barbiturates [e.g., phenobarbital], dexamethasone, antidepressants [e.g., fluoxetine, paroxetine], proton pump inhibitors, ketoconazole) 1 month before the start of the study (Day 1)
- Hypersensitivity or any significant allergic reaction to the investigational compound/compound class being used in this study or any ingredients of this medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AJA001AJA001 | Drug | Cohort A1: Single ascending dose of AJA001, Cohort A2: Single ascending dose of AJA001, Cohort A3: Single ascending dose of AJA001, Cohort A4: Single ascending dose of AJA001, Cohort B1: Multiple ascending doses of AJA001, Cohort B2: Multiple ascending doses of AJA001, Cohort B3: Multiple ascending doses of AJA001, Cohort B4: Multiple ascending doses of AJA001 |
| PlaceboPlacebo | Other | Cohort A1: Single ascending dose of placebo, Cohort A2: Single ascending dose of placebo, Cohort A3: Single ascending dose of placebo, Cohort A4: Single ascending dose of placebo, Cohort B1: Multiple ascending doses of placebo, Cohort B2: Multiple ascending doses of placebo, Cohort B3: Multiple ascending doses of placebo, Cohort B4: Multiple ascending doses of placebo |
Primary outcome
Adverse Events
Time frame: Up to 21 days
Incidence, severity and relationship of Adverse events (AEs)
Serious Adverse Events
Time frame: Up to 21 days
Incidence of Serious adverse events (SAEs)
Adverse Events of Special Interest
Time frame: Up to 21 days
Incidence of AEs of special interest (AESI), including abnormal clinically significant liver function test values (aspartate aminotransferase, alanine aminotransferase, total bilirubin and estimated glomerular filtration rate) due to major active pharmaceutical ingredient
Changes from baseline in hematology
Time frame: Up to 21 days
Number of participants with changes from baseline in hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, reticulocyte count, white blood cell count, and differential white blood cell count
Changes from baseline in serum chemistry
Time frame: Up to 21 days
Number of participants with changes from baseline in aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, sodium, potassium, chloride, calcium, magnesium, phosphorus, glucose, serum urea, uric acid, total bilirubin, creatinine, total protein, albumin, total cholesterol, triglycerides, creatinine phosphokinase, and follicle-stimulating hormone
Changes from baseline in urinalysis
Time frame: Up to 21 days
Number of participants with changes from baseline in microscopic examination, specific gravity, pH, protein, glucose, ketones, blood, urobilinogen, bilirubin, nitrites, leucocytes, immunoassay for THC
Changes from baseline in blood pressure
Time frame: Up to 21 days
Number of participants with changes from baseline in systolic and diastolic blood pressure in mm Hg
Changes from baseline in heart rate
Time frame: Up to 21 days
Number of participants with changes from baseline in pulse rate (beats/minute)
Changes from baseline in respiratory rate
Time frame: Up to 21 days
Number of participants with changes from baseline in respiratory rate (breaths/minute)
Changes from baseline in body temperature
Time frame: Up to 21 days
Number of participants with changes from baseline in body temperature (tympanic; °C)
Changes from baseline in ECG recording of heart rate
Time frame: Up to 21 days
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of heart rate in beats/minute
Changes from baseline in ECG recording of PR interval
Time frame: Up to 21 days
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of PR interval in msec
Changes from baseline in ECG recording of RR interval
Time frame: Up to 21 days
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of RR interval in msec
Changes from baseline in ECG recording of QRS duration
Time frame: Up to 21 days
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of QRS duration in msec
Changes from baseline in ECG recording of QT interval
Time frame: Up to 21 days
12-lead electrocardiogram (ECG) recordings of QT interval in msec
Changes from baseline in ECG recording of QTcF
Time frame: Up to 21 days
Number of participants with changes in 12-lead electrocardiogram (ECG) recordings of QTcF in msec
Clinically significant physical examination findings
Time frame: Up to 21 days
Number of participants with changes in the following parameters assessed during physical exams: general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes and nervous system
Changes in suicidal ideation and behavior
Time frame: Up to 21 days
Number of participants with changes in Columbia Suicide Severity Rating Scale evaluation of suicidal ideation (yes/no), intensity of ideation (1-5 with 1 being the least severe and 5 being the most severe), and suicidal behavior (yes/no; if yes, include the number of attempts)
Use of concomitant medications
Time frame: Up to 21 days
All medications taken after the first dose of the study drug and through the EOS visit will be considered a concomitant medication
17 secondary outcomes
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Cmin
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Cmax
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: Tmax
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: AUC0-last
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: AUC0-inf
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: lz
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohorts A and B: t1/2
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: Cl/F
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: Vz/F
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort A: CTlast
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: AUC0-tau
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Vd/F,ss
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Cl/F,ss
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: Aer
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: fe%
Time frame: Up to 21 days
Pharmacokinetics for primary cannabinoids and metabolites in Cohort B: CLr [Ae0-t/AUC0-t]
Time frame: Up to 21 days
Change from baseline in subjective pharmacodynamic effects
Time frame: Up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristi McLendon, MD principal investigator
Q-Pharm Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AJA001 in people with Healthy Volunteers, run by AJNA Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 21 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.