NCT03762031已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
研究概览
简要总结
The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between 18 and 50 years
- •Subjects who provide written informed consent
- •Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
- •Subjects in general good health
- •Blood pressure and pulse within normal limits
- •Male subjects must practice effective contraception
- •Female subjects must:
- •Have a negative serum pregnancy test during
- •Be non-lactating;
- •Be at least 2 years postmenopausal, surgically sterile, or practicing effective contraception.
排除标准
- •History of clinically significant illness or medical history which would preclude them from the study.
- •Known contraindication, hypersensitivity and/or allergy to study drugs
- •Use of any prescription or over-the-counter medication within one week prior to study drug administration
- •Anticipated need for any medication during the study
- •Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
- •Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
- •Presence of orthostatic hypotension at screening
- •Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
- •Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- •Known history of substance abuse, drug addiction, or alcoholism within 3 years
- •Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
- •Positive drug and alcohol toxicology screens during Screening
- •History of smoking or any use of a tobacco product within 6 months
- •Donation of blood or blood products within 30 days before Baseline and throughout the study;
- •Mentally unstable or incapable of being compliant with the protocol
- •Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
- •Subject has previously participated in this study, or in a prior Galera study
研究组 & 干预措施
GC4711 75mg
Experimental
干预措施: GC4711 75mg (Drug)
GC4711 30mg
Experimental
干预措施: GC4711 30mg (Drug)
GC4711 60mg
Experimental
干预措施: GC4711 60mg (Drug)
GC4711 90mg
Experimental
干预措施: GC4711 90mg (Drug)
GC4711 120mg
Experimental
干预措施: GC4711 120mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
GC4711 105mg
Experimental
干预措施: GC4711 105mg (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
时间窗: From randomization through study completion (estimated up to 3 days)
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities
次要结局
未报告次要终点
研究者
研究点 (1)
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