NCT03099824已完成1 期
A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or 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
- 56
- 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 purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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 (inclusive) of age;
- •Subjects who provide written informed consent
- •Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;
- •Subjects in general good health in the investigator's opinion
- •Chest X-ray free of clinically significant abnormalities
- •Blood pressure and heart rate within normal limits
- •Female subjects must:
- •Have a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline, and be willing and able to use a medically acceptable method of birth control or be postmenopausal.
- •Be non-lactating
- •Be at least two years postmenopausal, surgically sterile or practicing effective contraception
排除标准
- •History of clinically significant illness, medical condition, or laboratory abnormality within three months
- •History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;
- •History of hypotension
- •Known contraindication, hypersensitivity and/or allergy to investigational products
- •Use of any prescription or over-the-counter medication within one week prior to baseline;
- •Anticipated need for any medication during the course of the study
- •Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors (e.g., sildenafil, tadalafil, or similar agents), from 24 hours prior to screening throughout participation in the study;
- •Use of or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
- •Presence of orthostatic hypotension at screening or baseline
- •Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use of any vitamin or mineral supplement throughout the duration of the study;
- •Positive HIV, Hepatitis B or Hepatitis C serology at Screening;
- •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 prior to the administration of study drug and throughout the duration of the study;
- •Positive drug and alcohol toxicology screens during Screening and at Baseline;
- •History of smoking or any use of a tobacco product within six months prior to Baseline;
- •Donation of blood or blood products within 30 days prior to the Baseline and through duration of study;
- •Mentally unstable or incapable of being compliant with the protocol
- •Receipt of an investigational test substance within three months prior to the first dose of investigational products (GC4419, GC4711, or placebo), or anticipated receiving any investigational products (including placebo on another investigational study) other than GC4711 and GC4419 during the course of this study;
- •Subject has previously participated in this study, or in a prior study of GC4419, GC4711 or GC4702.
研究组 & 干预措施
GC4419 IV + GC4711 Oral G-101 (82mg)
Experimental
干预措施: GC4711 Oral Capsule G-101 (Drug)
GC4419 IV + GC4711 Oral G-101 (82mg)
Experimental
干预措施: IV GC4419 (Drug)
GC4419 IV + GC4711 Oral G-101 (164mg)
Experimental
干预措施: IV GC4419 (Drug)
GC4419 IV + GC4711 Oral G-101 (164mg)
Experimental
干预措施: GC4711 Oral Capsule G-101 (Drug)
GC4419 IV + GC4711 Oral G-101 (246mg)
Experimental
干预措施: IV GC4419 (Drug)
GC4419 IV + GC4711 Oral G-101 (246mg)
Experimental
干预措施: GC4711 Oral Capsule G-101 (Drug)
GC4419 IV + GC4711 Oral G-111 (175mg)
Experimental
干预措施: IV GC4419 (Drug)
GC4419 IV + GC4711 Oral G-111 (175mg)
Experimental
干预措施: GC4711 Oral Capsule G-111 (Drug)
GC4419 IV + GC4711 Oral G-112 (145mg)
Experimental
干预措施: IV GC4419 (Drug)
GC4419 IV + GC4711 Oral G-112 (145mg)
Experimental
干预措施: GC4711 Oral Capsule G-112 (Drug)
GC4711 IV + GC4711 Oral G-119 (233mg)
Experimental
干预措施: GC4711 Oral Capsule G-119 (Drug)
GC4711 IV + GC4711 Oral G-119 (233mg)
Experimental
干预措施: IV GC4711 (Drug)
GC4711 IV + GC4711 Oral G-125 (233mg)
Experimental
干预措施: GC4711 Oral Capsule G-125 (Drug)
GC4711 IV + GC4711 Oral G-125 (233mg)
Experimental
干预措施: IV GC4711 (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 13 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)
Loading locations...
相似试验
已完成
1 期
MEDI2228 in Subjects With Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT03489525MedImmune LLC107
已完成
1 期
A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid MalignanciesAdvanced Solid MalignanciesNCT03980821AstraZeneca10
进行中（未招募）
1 期
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid TumorsOvarian CancerGastric CancerNCT06714617SystImmune Inc.120
已完成
1 期
Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid TumorsMetastatic Adenocarcinoma of the Colon or RectumMalignant Solid TumorsNCT01765790Baxalta now part of Shire68
已完成
1 期
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid MalignanciesAdvanced Solid MalignanciesNCT03394144AstraZeneca11