A Phase 1, Randomized, Placebo Controlled, Double-Blind, Single Dose Escalation Study of NoNO-42 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- NoNO Inc.
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Frequency of AEs, abnormal laboratory findings and abnormal vital signs
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending intravenous dose of NoNO-42 administered to healthy adults.
Participants will be administered a single intravenous dose of NoNO-42 or placebo.
Participants will be confined for 24 hours post dose with a follow-up visit at Day 4 and Day 28.
详细描述
The trial was a single, adaptive dose, dose escalation study in healthy male and female adults.
The trial was randomized, double-blind, placebo controlled and evaluated the safety, tolerability, and PK of IV NoNO-42 in healthy adults. Each healthy volunteer was administered a single IV dose of study drug or placebo.
It was planned that up to 10 dosing cohorts would be evaluated. A cohort may have been repeated or added if necessary. Cohort 1 included 4 healthy volunteers (1:1 randomization of NoNO-42 to placebo) with a sentinel dose of 2 healthy volunteers (1:1). Cohorts 2 to 10 were to include 10 new healthy volunteers dosed at each dose level (4:1 randomization of NoNO-42 to placebo) during the single dose escalation. Sentinel dosing with 2 healthy volunteers (1:1) occurred at each dose escalation. Both the dose concentration and the dosing duration may have been adjusted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures, clinic visits, blood draws, and availability for the duration of the study
- •Healthy adult male or female aged 18 to 60 years old.
- •Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
- •Body weight less than or equal to 120 kg
- •Good bilateral venous access sufficient for IV infusions as judged by the investigator or designee
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
排除标准
- •Female who is lactating or pregnant
- •History of significant hypersensitivity to NoNO-42 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, renal, hepatic, or dermatologic disease
- •Presence of clinically significant ECG abnormalities, or any QT interval abnormalities, at the screening visit, as defined by medical judgment
- •Immunization with a COVID-19 vaccine in the 14 days prior to the first study drug administration or plans for vaccination
- •Blood pressure below 100 mmHg systolic and 60 mmHg diastolic, and any upper limit is deemed clinically significant by the investigator
- •Estimated glomerular filtration rate (eGFR) of <60 mL/min.
研究组 & 干预措施
NoNO-42
A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute
干预措施: NoNO-42 (Drug)
Placebo
A volume of 0.9% normal saline matching the volume required for a weight-based dosing of NoNO-42, administered as a single 10±1 minute intravenous infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of AEs, abnormal laboratory findings and abnormal vital signs
时间窗: 28 days
* Incidence, severity, and causal relationship of AEs. * Incidence of abnormal laboratory findings, including histamine. * Incidence of abnormal vital signs (blood pressure, heart rate, temperature) and electrocardiogram (ECG) parameters
次要结局
- Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose(24 hours)