None listed
Conditions
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
Interventions
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 b
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.
Sponsors
George Clinical Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed