ACTRN12620000949987已完成1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Healthy adult volunteers between 18 and 45 years of age, inclusive at the time of informed consent.
- •2.In good general health as determined by medical history, physical examination, vital signs, laboratory tests, and ECG.
- •3.Have a body weight in the range of 50 to 120 kg, inclusive, and a BMI of 19 to 28 kg/m2, inclusive, at Screening.
- •4.Agree to abstain from alcohol intake for 24 hours prior to IP administration and 24 hours prior to all other outpatient clinic visits.
- •5.Agree not to use prescription medications (except for birth control) within 14 days prior to IP administration and for the duration of the study, unless approved by the PI and Sponsor MM.
- •6.Agree not to use OTC medications and herbal medication within 14 days prior to IP administration through to the final Follow-up visit
- •7.Agree to refrain from participation in a competitive collision sport from the initiation of the Screening period until completion of the study (Day 28 telephone follow-up).
- •8.Women of Child-bearing Potential must be non-pregnant and must use an acceptable, highly effective double barrier contraception from Screening until study completion, including the follow up period.
- •9.Must have signed an informed consent document indicating that they understand the purpose of the study and the procedures that are required, and that they are willing to participate in the study.
- •10.Must be willing and able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol.
排除标准
- •1.Females who are pregnant or nursing at Screening.
- •2.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.
- •3.History of seizures or epilepsy within the past 5 years.
- •4.History of moderate to severe traumatic brain injury
- •5.History of concussion within the past 1 year.
- •6.Currently have or have a history of any clinically significant medical illness or medical disorders the Investigator considers should exclude the participant
- •7.Psychiatric or behavioural condition which would compromise participation in the study.
- •8.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.
- •9.Major or traumatic surgery within 12 weeks of Screening.
- •10.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.
- •11.Positive serology test for HIV antibodies, HbsAg, or HCV antibodies at Screening.
- •12.Recent history (within previous 6 months) of alcohol or drug abuse.
- •13.Have smoked tobacco or related products within 3 months prior to dosing.
- •14.Have positive urine drug test at Screening and/or at any time during the study for substances of abuse
- •15.Have a positive alcohol breath test at Screening and/or at any time during the study.
- •16.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.
- •17.Donated blood within 60 days prior to Screening.
- •18.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.
- •19.Received any other experimental therapy including device or an investigational agent within 30 days or 5 half lives (whichever is longer) of IP administration.
- •20.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.
研究者
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