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Trial registered on ANZCTR


Registration number
ACTRN12622001351707
Ethics application status
Approved
Date submitted
14/10/2022
Date registered
21/10/2022
Date last updated
18/08/2024
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study of MAXONA Pharmaceuticals MAX-001 healthy subjects for the evaluation of safety, tolerability, and drug concentrations in progressively increasing single and multiple daily dose levels
Scientific title
Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of MAX-001 in Healthy Subjects
Secondary ID [1] 308191 0
MAXONA Pharmaceuticals Study MAX-001-101 Stage 2 and 3
Universal Trial Number (UTN)
U1111-1283-4547
Trial acronym
Linked study record
This study is a follow-up of ACTRN12622001348741

Health condition
Health condition(s) or problem(s) studied:
Various pain indications 327932 0
Condition category
Condition code
Anaesthesiology 325000 325000 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MAX-001-101 Stage 2 and 3 are a single ascending dose and multiple ascending dose study respectively. Stage 3 may be initiated prior to, or at the completion of Stage 2, based on the determinations of the Safety Monitoring Committee. Each study part and stage will involve unique participants.

Stage 2: Single ascending dose cohorts
Stage 2 evaluates the single-dose administration of the formulation of MAX-001 selected in Part 1 or matched placebo (a tablet that looks the same as the study drug but has no active substances): 60mg, 120mg, 180mg, and 240mg respectively in cohorts 1-4. Each cohort will consist of 8 participants who will each receive a single dose of investigational drug or matched placebo under fasted state (after an overnight fast of at least 10 hours prior to dosing), Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff.

Stage 3: Multiple ascending dose cohorts
Two cohorts of 8 participants and one cohort of 12 participants will each receive the formulation of MAX-001 selected in Part 1 or matched placebo (a tablet that looks the same as the study drug but has no active substances): 60mg once daily, 120mg once daily, and 120mg twice daily given by oral administration for 7 days. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff.
Intervention code [1] 324642 0
Treatment: Drugs
Comparator / control treatment
Matching placebo: tablets with exact same composition as active drug product minus active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 332812 0
Safety and tolerability will be assessed by clinical monitoring and will assess change from baseline for physical exams, vital signs, hematology, chemistry and urinalysis labs, 12-lead electrocardiograms (ECGs), and adverse events reporting. Adverse events will be reported by the participant. The Investigator and any designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. Events meeting the AE definition include: • Any abnormal laboratory test results (hematology, coagulation, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, vital signs measurements, or physical examinations), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator. • Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. • New conditions detected or diagnosed after study drug administration although it may have been present before the start of the study. • Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. • Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be reported regardless of sequelae. Severity categories of AE assessment include mild, moderate, and severe, as defined below- • Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living • Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research subject. • Severe: A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Vital signs measurements will include tympanic body temperature, pulse rate, and blood pressure. Blood pressure and pulse rate will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available.
Timepoint [1] 332812 0
Stage 2: Clinical laboratory blood tests will be assessed at Screening and on Day -1, Day 2, Day 3, Day 4, Day 5, and Day 8. Clinical laboratory urinalysis will be assessed at Screening and on Day -1, Day 2, Day 3, Day 4, and Day 8. A complete physical examination will be assessed at Screening, while symptom-directed physical examinations will be assessed on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 8. Vital signs will be assessed at Screening and on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 8. 12-Lead ECG will be assessed Screening and on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 8. AEs/SAEs will be assessed at all timepoints.
Stage 3: Clinical laboratory blood tests will be assessed at Screening and on Day -1, Day 2, Day 4, Day 9, Day 11, and Day 13. Clinical laboratory urinalysis will be assessed at Screening and on Day -1, Day 2, Day 4, Day 9, and Day 13. A complete physical examination will be assessed at Screening, while symptom-directed physical examinations will be assessed on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, and Day 13. Vital signs will be assessed at Screening and on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, and Day 13. 12-Lead ECG will be assessed Screening and on Day -1, Day 1, Day 2, Day 4, Day 9, Day 11, and Day 13. AEs/SAEs will be assessed at all timepoints.
Primary outcome [2] 332813 0
Pharmacokinetic (PK) profile: Cmax, Cmin, AUCinf, AUClast, Tmax, Tmin, and t ½
Timepoint [2] 332813 0
Stage 2 (SAD): blood samples collected at pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 60, and 72 hours post-dose.
Stage 3 (MAD) for once daily dosing: blood samples collected at pre-dose on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7. On Day 1 post dose samples will be collected at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours. On Day 7 post dose samples will be collected at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours.
Stage 3 (MAD) for twice daily dosing: blood samples collected at pre-dose on Day 1, Day 2, Day 3, Day 4, Day 5, and Day 6. On Day 1 post dose samples will be collected at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours. On Day 6, samples will be collected before the second daily dose and post dose at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, and 12 hours. On Day 7 post dose samples will be collected at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours.
Secondary outcome [1] 414766 0
Nil
Timepoint [1] 414766 0
Nil

Eligibility
Key inclusion criteria
- Able to understand, sign, and commit to informed consent and to all study procedures
- Adhere to effective double-barrier contraception or in proven post-menopause
- Healthy as determined during screening based on medical history, physical examination, vital signs, ECG (QTcF <=450 msec in males, QTcF <=470 in females), and laboratory assessments
- Body Mass Index 18 to 32.0 kg/m2
- Non-smokers or light smokers (less than 10 cigarettes per week)
- Commitment to adhere to lifestyle guidance during the study participation
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any lifetime antecedent, any disease or medication indicative of past seizures, including childhood febrile seizures, epilepsy, or any disease or medication that increases the risk of seizures or any family history of seizures or epilepsy
- Any antecedent of ischemic heart or cerebrovascular disease, angina, prior history of a myocardial infarction, stroke, transient ischemic attack (TIA), cervical artery dissection, QTcF > 450 msec in males and > 470 msec in females, QRS prolongation, arrhythmia, and prior occurrence of torsades de pointe as well as absence of family history of long QT syndrome or sudden cardiac death
- Any antidepressant use, such as a monoamine oxidase inhibitor like phenelzine, a tricyclic antidepressant such as amitriptyline or nortryptiline, or a single-, double-, or triple monoamine reuptake inhibitor (SSRI, SNRI, NDRI, NRI, SNDRI)
- Use of drowsiness-causing antihistamines, anticholinergics, sympathomimetics (including decongestant nasal sprays containing ephedrine), or antidepressants
- Serology indicative of HIV or hepatitis B or C
- Abnormal liver function tests
- Abnormal renal function tests as assessed by the creatinine clearance
- Past or current cancer and its treatment
- Glaucoma
- Substance use disorder in medical history, urine drug screen and alcohol breath test
- Mental health disorder diagnosis and/or treatment
- Pregnancy or breastfeeding

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Randomized double-blind placebo-controlled design
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Listings and tabulation of safety and tolerability variables
Pharmacokinetic analysis and modeling to estimate and visualize standard parameters
Sample size is based on customary practice in Phase 1 clinical studies

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
Date of last participant enrolment
Anticipated
19/11/2024
Actual
Date of last data collection
Anticipated
5/12/2024
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23372 0
Nucleus Network - Melbourne
Recruitment hospital [2] 23374 0
Nucleus Network - Geelong
Recruitment postcode(s) [1] 38757 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312446 0
Commercial sector/Industry
Name [1] 312446 0
MAXONA Australia Pty, Ltd
Country [1] 312446 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
George Clinical Pty Ltd
Address
Level 5, 1 King Street,
Newtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 314024 0
None
Name [1] 314024 0
Address [1] 314024 0
Country [1] 314024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311792 0
Alfred Health Ethics Committee
Ethics committee address [1] 311792 0
55 Commercial Rd,
Melbourne VIC 3004
Ethics committee country [1] 311792 0
Australia
Date submitted for ethics approval [1] 311792 0
04/10/2022
Approval date [1] 311792 0
02/11/2022
Ethics approval number [1] 311792 0

Summary
Brief summary
A Phase 1 clinical study in healthy subjects to evaluate the safety, tolerability, and plasma drug concentration profile resulting from the administration of single and multiple oral doses of MAXONA Pharmaceuticals MAX-001
Trial website
Trial related presentations / publications
Public notes
Exclusion criteria:
- Febrile illness or COVID-19 symptoms within 28 days prior to screening
- Positive PCR test for COVID-19 within 1 month prior to screening or at CRU admission and no exposure to contact(s) with clinical COVID-19 symptoms within the last 14 days
- COVID-19 vaccination within 30 days prior to study drug administration

The lifestyle guidelines applicable to participants in this study are captured in the Participant Information Sheet and Informed Consent (PICF) and will be explained during the consenting process. As specified within the PICF, participants will be requested to abstain from certain foods, alcohol, tobacco products, and unaccustomed exercise prior to and during admission to the clinical research unit.

Contacts
Principal investigator
Name 122382 0
Dr Sam Francis
Address 122382 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122382 0
Australia
Phone 122382 0
+61 481 843 422
Fax 122382 0
Email 122382 0
[email protected]
Contact person for public queries
Name 122383 0
Sam Francis
Address 122383 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122383 0
Australia
Phone 122383 0
+61 481 843 422
Fax 122383 0
Email 122383 0
[email protected]
Contact person for scientific queries
Name 122384 0
Sam Francis
Address 122384 0
Nucleus Network Pty Ltd
Level 1,
484 St Kilda Road,
Melbourne VIC 3004
Country 122384 0
Australia
Phone 122384 0
+61 481 843 422
Fax 122384 0
Email 122384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be released in any form


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.