NCT02722083终止2 期
A Single-blind, Randomized, Placebo Controlled, Crossover Pilot Study to Evaluate the Onset of Action of an Antihistamine in Subjects Following Allergen Exposure in an Allergen Chamber
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 1
- 主要终点
- The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)
研究概览
简要总结
The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.
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
- Single (Participant)
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
- 否
入选标准
- •Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;
- •Self-reported to have seasonal allergic rhinitis for at least 2 years prior
- •Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal > 4mm larger than the diluent within the previous 12 months
- •Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;
- •Body Mass Index (BMI) in the range of 18 to 30 kg/m2
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP administration on Day 1 and Day 7 ± 1 day. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy
排除标准
- •Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
- •Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
- •Self-reported non-responders (lack of therapeutic effect) to antihistamines
- •Administration of epinephrine is contra-indicated;
- •Current use of oral steroids, including prednisone and prednisolone;
- •Females who are pregnant or lactating
- •A history of anaphylaxis to ragweed allergen
- •Subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; At the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be given a placebo
干预措施: Placebo (Drug)
BAY X002134
Experimental
Subjects will be given BAY X002134
干预措施: Chlorpheniramine maleate (BAY X002134) (Drug)
结局指标
主要结局
The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)
时间窗: 4 hours
次要结局
- Number of patients with adverse events as a measure of safety(3 month)
研究者
相似试验
已完成
1 期
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy ParticipantsHealthy ParticipantsNCT05107336AstraZeneca44
已完成
1 期
Sugammadex Hypersensitivity Study (Study P06042)HypersensitivityNCT00988065Merck Sharp & Dohme LLC448
已完成
1 期
A Study of Plasma-Derived Human Butyrylcholinesterase Administered IntramuscularlyHealthy VolunteersNCT00333528Baxalta now part of Shire8
已完成
1 期
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022HyperlipemiaNCT05912296Suzhou Ribo Life Science Co. Ltd.80
已完成
1 期
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered IntravenouslyHealthy VolunteersChemical TerrorismChemical WarfareNCT00333515Baxalta now part of Shire28