NCT01793649终止1 期
A Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Area under the curve of MCC from Whole Lung Compartment
研究概览
简要总结
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Body mass index (BMI) from ≥ 19 to ≤ 30 kg/m2
- •Normal ECG, with no history or evidence of myocardial infarction, QT prolongation, or ventricular arrhythmias
- •Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR)
- •History of lifetime smoking < 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to Screening
- •Negative screening tests for drugs of abuse (including alcohol)
- •Hepatitis B (HBV) surface antigen negative
- •Hepatitis C (HCV) antibody negative
- •HIV-1, 2 antibody negative
- •Male subjects who are sexually active must be willing to use highly effective contraception from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
- •Male subjects must refrain from sperm donation from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
- •Females of childbearing potential must have a negative serum pregnancy test
- •Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study treatment and for 30 days following the last dose of study drug
排除标准
- •Female subjects who are pregnant or lactating
- •History of anaphylactic reaction to any drug
- •Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing
- •Presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months
- •Have donated blood within 56 days of study dosing
- •Presence or history of any pulmonary diseases (ie, asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis, interstitial lung disease)
- •Major surgery within 6 months of Screening
- •Experienced symptoms of recent acute upper or lower respiratory tract infection requiring treatment within the 2 weeks prior to Screening
- •Have had any radiation in the past year that would cause the subject exceed recommended limits by participating in this study protocol
研究组 & 干预措施
Cross-Over Sequence 1
Experimental
85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded)
干预措施: GS-5737 (Drug)
Cross-Over Sequence 2
Experimental
2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded)
干预措施: GS-5737 (Drug)
结局指标
主要结局
Area under the curve of MCC from Whole Lung Compartment
时间窗: 4 weeks
The primary endpoint of this study will be the calculated area under the curve of MCC from the whole lung compartment, assessed through 60 minutes post isotope dosing (AUC-60min), which will provide a description of the MCC curve.
次要结局
- Area under the curve of MCC from Central and Peripheral Lung(4 weeks or duration of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy VolunteersHealthy VolunteersHealthyNCT03194139Galera Therapeutics, Inc.36
已完成
1 期
Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis PatientsOnychomycosisNCT01841996Meiji Seika Pharma Co., Ltd.24
Unknown
1 期
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral DrugHealthyNCT05234320Caregen Co. Ltd.16
终止
1 期
Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus SubjectsDiabetes MellitusNCT01755442Amgen5
已完成
1 期
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 DiabetesDiabetes Mellitus, Type 1NCT02506647Gan and Lee Pharmaceuticals, USA41