A Phase 1 Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study of CNM-Au8 in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Tmax
研究概览
简要总结
This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind, escalating single- and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD Phase will be conducted first followed by the MAD phase of the study.
详细描述
SAD Phase:
A total of 8 subjects will be randomly assigned in a 3:1 ratio to receive a single dose of either CNM-Au8 (n=6) or placebo (n=2) at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 8 subjects will be enrolled to investigate escalating single doses of CNM-Au8 at 30, 60, and 90 mg. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.
MAD Phase:
A total of 12 subjects will be randomly assigned in a 3:1 ratio to receive a multiple dose of either CNM-Au8 (n=9) or placebo (n=3) once daily for 21 days at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 12 subjects will be enrolled to investigate escalating multiple doses of CNM-Au8 at 30, 60, and 90 mg CNM Au8 administered once daily for 21 days. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- •Females will be non-pregnant, non-lactating, or post-menopausal
- •All laboratory values at screening fall within normal range or are evaluated as not clinically significant
- •Has not consumed and agrees to abstain from taking any dietary supplements or non-prescription drugs
- •Has not consumed and agrees to abstain from taking any prescription drugs
- •Has not consumed alcohol-containing beverages
- •Has not consumed grapefruit or grapefruit juice
- •Has not used tobacco- and nicotine-containing products
- •Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
排除标准
- •Has a history of illicit drug abuse
- •Has clinically significant medical or psychiatric history
- •Has donated plasma or excessive blood loss
- •Prior participation in another clinical trial
研究组 & 干预措施
CNM-Au8
CNM-Au8 is an orally administered, clean-surface gold nanocrystal suspension drug. It is atomically clean-surface elemental nanocrystals, free of any residual surface chemicals or surface-capping agents.
CNM-Au8 15, 30, 60, 90mg as an oral suspension
干预措施: CNM-Au8 (Other)
Placebo
Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
干预措施: Placebo (Other)
结局指标
主要结局
Tmax
时间窗: Single dose and up to 21 days of consecutive daily dosing
Time to Cmax
CL/F
时间窗: Single dose and up to 21 days of consecutive daily dosing
The apparent systemic clearance
t 1/2
时间窗: Single dose and up to 21 days of consecutive daily dosing
Terminal phase half-life
Treatment emergent adverse and serious adverse events
时间窗: 49 days
Occurrence of adverse events
Cmax
时间窗: Singe dose and up to 21 days of consecutive daily dosing
Maximum observed plasma concentration
次要结局
- Changes in cytokine levels(Following a single oral dose or multiple oral doses (once daily for 21 consecutive days))