A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events from dosing through follow-up
研究概览
简要总结
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.
详细描述
Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later.
Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo.
A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed.
Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg.
- •Use of highly-effective methods of birth control
- •Willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit
排除标准
- •A clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease
- •A history of asymptomatic or mild COVID within 30 days of study drug administration
- •A history of hospitalization with COVID within 6 months prior to study drug administration
- •A history of COVID vaccination within 1 month prior to study drug administration
研究组 & 干预措施
Single ascending doses of cNP8
Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose.
干预措施: cNP8 (Drug)
Single doses of placebo administered
Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2).
干预措施: Placebo (Other)
结局指标
主要结局
Incidence and severity of adverse events from dosing through follow-up
时间窗: Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up
Vital signs
次要结局
- Pharmacokinetic profile(Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose)