A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
研究概览
简要总结
The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
详细描述
It has been discovered that SARS-CoV-2 viruses (Covid-19) can directly invade the nervous system of patients, instead of injuring the nervous system through the immune response. Neurotropism is one common feature of Covid-19. Such neuro-invasive propensity of Covid-19 has been documented almost for all the Beta-coronaviruses including SARS-CoV and MERS-CoV.
Increasing evidence suggests that infection with Sars-CoV-2 causes neurological deficits in a substantial proportion of affected patients. It was observed that patients surviving COVID-19 are at high risk for subsequent development of neurological disease and in particular Alzheimer's disease.
NA-831 is a new neuroprotective and neurogenesis drug that has been demonstrated its promising safety and efficacy in Phase 2A for the treatment of early onset of Alzheimer's disease. NA-831 in oral formulation is well tolerated NA-831 with no adverse effects. NA-831 in oral formulation exhibits predictable pharmacokinetics including dose-dependent exposure linearity and low variability.
Based on animal studies, NA-831 can provide effective interventions during the severe acute respiratory syndrome, and provide appropriate rehabilitation measures afterwards.
Remdesivir (GS-5734) intravenous formulation has been approved by the FDA under the emergency use authorization for potential treatment of severe cases of Covid-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Comparable Placebo- 0.10 mg/kg
3 subjects will take inhaled formulation of placebo once a day for 5 days
干预措施: Placebo- 0.10 mg/kg (Drug)
Comparable Placebo- 0.20 mg/kg
3 subjects will take inhaled formulation of placebo once a day for 5 days
干预措施: Placebo- 0.20 mg/kg (Drug)
Comparable Placebo- 1.00 mg.kg
3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
干预措施: Placebo- 1.00 mg/kg (Drug)
Comparable Placebo - 2.00 mg/kg
3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
干预措施: Placebo- 2.00 mg/kg (Drug)
Placebo- 0.10- mg/kg placebo+1.00 mg mg/kg
3 Subjects - inhaled formulation of placebo once/day for 5 days
干预措施: Placebo 0.10 mg + 1.00 mg/kg (Combination Product)
Placebo- 0.20 mg/kg + 2.00mg/kg
3 Subjects- inhaled formulation of placebo once/day for 5 days
干预措施: Placebo 0.20 mg + 2.00 mg/kg (Combination Product)
结局指标
主要结局
Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
时间窗: First dose date up to Day 30 Follow-up Assessment
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
时间窗: First dose date up to Day 30 Follow-up Assessment
This will be assessed at various time points by clinical laboratory tests and vital signs.
次要结局
- AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment(7 days)
- Area Under the Curve Extrapolated to Infinity (AUC0-∞)(7 days)
- Half-Life (t1/2) - Pharmacokinetic Assessment(7 days)
- Volume of Distribution (Vd) - Pharmacokinetic Assessment(7 days)
- Clearance [CL] - Pharmacokinetic Assessment(7 days)
- Maximum Concentration (Cmax) - Pharmacokinetic Assessment(7 days)
- Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment(7 days)