An Open-label, Single Arm, Pilot Study of the Feasibility of Measuring the Effect of Intranasal Acetylcysteine on Neurometabolic Markers Using Proton Magnetic Resonance Spectroscopy

Exclusion Criteria20

• Females who are pregnant or nursing at Screening.
• Have a deformity of the nasal cavity, a known septum deviation; or recent (<5 years) history of surgery of the nasal cavity and/or nasopharynx.
• History of seizures or epilepsy within the past 5 years.
• History of moderate to severe traumatic brain injury
• History of concussion within the past 1 year.
• Currently have or have a history of any clinically significant medical illness or medical disorders the Investigator considers should exclude the participant
• Psychiatric or behavioural condition which would compromise participation in the study.
• Acute upper respiratory illness including a common cold, within 14 days prior to IP administration or have had a major illness or hospitalisation within 1 month of Screening.
• Major or traumatic surgery within 12 weeks of Screening.
• Any participant who plans to undergo elective surgery within 4 weeks prior to IP administration and through the end of the study including the follow-up period.
• Positive serology test for HIV antibodies, HbsAg, or HCV antibodies at Screening.
• Recent history (within previous 6 months) of alcohol or drug abuse.
• Have smoked tobacco or related products within 3 months prior to dosing.
• Have positive urine drug test at Screening and/or at any time during the study for substances of abuse
• Have a positive alcohol breath test at Screening and/or at any time during the study.
• Consume, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products) per day.
• Donated blood within 60 days prior to Screening.
• Have a history of active drug and/or food allergy or other active allergic disease requiring the constant use of medications, or a history of severe allergic reaction, angioedema or anaphylaxis.
• Received any other experimental therapy including device or an investigational agent within 30 days or 5 half lives (whichever is longer) of IP administration.
• Are unable to undergo MRI scanning due to the presence of non-removable metal implants, including but not limited to surgical staples, pacemaker, steel IUD etc, claustrophobia or any other contraindication.