NCT02133339已完成1 期
A Phase I, Randomized, Double-blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of Nebulized, TRN-157 Inhalation Solution in Healthy Subjects
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
- 30
- 主要终点
- Safety and tolerability as determined by number of subjects with adverse events
研究概览
简要总结
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has provided written informed consent
- •The subject is male or female 18 to 65 years of age
- •If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
- •Good general health
- •Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
- •The subject is compliant and available throughout the entire study period
排除标准
- •Current diagnosis, as per subject or investigator or screening assessment, of:
- •unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
- •history of narrow angle glaucoma
- •history of alcohol abuse within the past 5 years
- •history of smoking within the past 6 months
- •positive result for the alcohol and/or drugs of abuse
- •weight > 100 kg or < 50 kg
- •clinically significant abnormal ECG
- •history of clinically significant (per the Investigator) disease or disorder
- •any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
- •Abnormal vital signs defined as any of the following:
- •Systolic blood pressure ≥ 140 mmHg
- •Diastolic blood pressure ≥ 90mmHg
- •Heart rate < 40 or > 85 beats per minute
- •Fever or other clinically significant physical exam findings
- •Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- •History or current symptom(s) of respiratory tract inflammation
- •Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
- •Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
- •FEV1 variability > 10% between study visits
- •Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
- •Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
- •Inability to perform acceptable, quality serial spirometry or any other study procedures
- •Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody
研究组 & 干预措施
TRN-157
Experimental
干预措施: TRN-157 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability as determined by number of subjects with adverse events
时间窗: 1 week
次要结局
- Determination of pharmacokinetic parameters(1 week)
研究者
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