NCT01793298终止1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ASM-024 Administered by Dry Powder Inhalation to Healthy Subjects and Subjects With Stable Moderate Asthma
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
- 55
- 试验地点
- 2
- 主要终点
- adverse events, spirometry
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
详细描述
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma. The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024. The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers. In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers:
- •Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
- •Normal lung function; and
- •Normal 12-lead ECG
- •Asthmatics:
- •Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
- •Non-smoker or former smoker;
- •FEV1 ≥ 70 % predicted in the absence of medications for asthma;
- •Baseline methacholine PC20 ≤ 16 mg/mL; and
- •Normal 12-lead ECG.
排除标准
- •Healthy Volunteers:
- •Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- •Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- •History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- •History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- •Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- •Positive pregnancy test for female subjects;
- •Use of medications known to prolong QT/QTc interval within 14 days prior to the first administration of the study medication;
- •Clinically significant 12 lead ECG abnormalities at Screening;;
- •Clinically significant physical examination or laboratory findings at Screening;
- •History of alcohol or drug abuse;
- •Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- •Positive hepatitis B or C or HIV test at Screening;
- •Investigational drug within 30 days prior to first administration of the study medication, or long-acting investigational drug within 90 days prior to first administration of the study medication;
- •Previous exposure to ASM-024; and
- •Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
- •Asthmatics:
- •Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- •Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- •History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- •History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- •Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- •Positive pregnancy test for female subjects;
- •Use of medications known to prolong QT/QTc interval;
- •Clinically significant 12 lead ECG at Screening;
- •Clinically significant physical examination or laboratory findings or abnormal vital signs;
- •Baseline methacholine PC20 > 16 mg/mL at Screening;
- •History of illicit drug use or alcohol abuse within 12 months of Screening;
- •Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- •Positive hepatitis B or C or HIV test at Screening;
- •Any of the following concomitant medications preceding the administration of methacholine during Screening and preceding the administration of the study medication at Visit 1: (i) oral or i.v. corticosteroids within 1 month; (ii) inhaled or intranasal corticosteroids within 48 hours; (iii) long-acting beta-2-agonists within 48 hours; (iv) short-acting beta-2-agonists within 8 hours; (v) anticholinergic aerosol within 24 hours; (vi) theophyline-containing products within 48 hours; (vii) NSAIDs within 7 days preceding the administration of methacholine during Screening and throughout the study; and (viii) antihistaminic drugs within 3 days;
- •Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of Screening;
- •Previous exposure to ASM-024; and
- •Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
研究组 & 干预措施
Healthy Subjects - ASM-024 Single Administration
Experimental
Single administration of ascending doses of ASM-024
干预措施: ASM-024 (Drug)
Healthy Subjects - ASM-024 Repeat Administration
Experimental
Repeat administration of ascending doses of ASM-024
干预措施: ASM-024 (Drug)
Subjects with Asthma
Experimental
Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion
干预措施: ASM-024 (Drug)
结局指标
主要结局
adverse events, spirometry
时间窗: up to 7 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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