NCT03570957已完成1 期
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
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
- 75
- 试验地点
- 1
- 主要终点
- Safety and tolerability as measured by incidence of adverse events
研究概览
简要总结
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A body weight of 40 to 100 kg for female or 45 to 100 kg for male
- •A body mass index of 18 to 30 kg/m2
- •Subjects who have current history of JC-SAR in previous 2 consecutive years.
- •Presence (CAP-RAST: ≥2) of IgE specific to Japanese cedar pollens and absence (CAP-RAST: ≤1) of IgE specific to other 4 allergens
- •Presence of at least 2 symptoms, which are moderate to very severe, in 4 nasal symptoms (runny nose, sneezing, blocked nose, itchy nose) at any time point during allergen exposure in EEC at screening period
排除标准
- •Presence of any symptoms of allergic rhinitis within 1 year except scattering season of cedar pollen or cypress pollen
- •Subjects who have persistent symptom caused by allergen exposure in EEC at screening period until Day 1 (pre-dose)
- •Underwent nasal surgery (include laser surgery) to improve nasal symptoms within 2 years
- •Underwent specific immunotherapy or non-specific immunotherapy within 5 years
- •Underwent medication of anti-histamine, oral mast cell stabilizer, leukotriene receptor antagonist, prostaglandin D2/thromboxane A2 receptor antagonist, Th2 cytokine inhibitor, corticosteroid (oral form, intra-nasal form, ocular form), or vasoconstrictor within 4 weeks
- •Underwent medication of corticosteroid (injection form) or anti-IgE antibody within 6 months
- •Subject who is concerned about exacerbation of the physical condition due to allergen exposure in EEC
研究组 & 干预措施
Placebo
Placebo Comparator
Single intravenous dose
干预措施: Placebo (Drug)
MT-2990, Low dose
Experimental
Single intravenous dose
干预措施: MT-2990 (Drug)
MT-2990, Low dose
Experimental
Single intravenous dose
干预措施: Placebo (Drug)
MT-2990, Low-middle dose
Experimental
Single intravenous dose
干预措施: MT-2990 (Drug)
MT-2990, Low-middle dose
Experimental
Single intravenous dose
干预措施: Placebo (Drug)
MT-2990, High-middle dose
Experimental
Single intravenous dose
干预措施: MT-2990 (Drug)
MT-2990, High-middle dose
Experimental
Single intravenous dose
干预措施: Placebo (Drug)
MT-2990, High dose
Experimental
Single intravenous dose
干预措施: MT-2990 (Drug)
结局指标
主要结局
Safety and tolerability as measured by incidence of adverse events
时间窗: Up to Day 113
Proportion of subjects who develop antibodies against MT-2990 in serum
时间窗: Up to Day 113
次要结局
- MT-2990 concentration in serum(Up to Day 113)
- Apparent terminal elimination half-life (t1/2) of MT-2990(Up to Day 113)
- Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990(Up to Day 113)
- AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990(Up to Day 113)
- AUC from time zero to infinity (AUC0-∞) of MT-2990(Up to Day 113)
- Mean residence time from time zero to infinity (MRT0-∞) of MT-2990(Up to Day 113)
- Apparent serum clearance (CL) of MT-2990(Up to Day 113)
- AUC of TOSS after allergen exposure(Day 8, 29, 57, and 85)
- AUC of TSS after allergen exposure(Day 8, 29, 57, and 85)
- Proportion of subjects with increased TNSS from baseline(Day 8, 29, 57, and 85)
- Proportion of subjects with increased TOSS from baseline(Day 8, 29, 57, and 85)
- Proportion of subjects with increased TSS from baseline(Day 8, 29, 57, and 85)
- Measured time of maximum observed serum concentration (tmax) of MT-2990(Up to Day 113)
- Terminal elimination rate constant (kel) of MT-2990(Up to Day 113)
- Apparent volume of distribution at steady state (Vss) of MT-2990(Up to Day 113)
- Change from baseline in TNSS(Day 8, 29, 57, and 85)
- Change from baseline in TOSS(Day 8, 29, 57, and 85)
- Change from baseline in TSS(Day 8, 29, 57, and 85)
- Sum of TNSS during allergen exposure in EEC(Day 8, 29, 57, and 85)
- Sum of TOSS during allergen exposure in EEC(Day 8, 29, 57, and 85)
- Sum of TSS during allergen exposure in EEC(Day 8, 29, 57, and 85)
- AUC of TNSS after allergen exposure(Day 8, 29, 57, and 85)
- Maximum observed serum concentration (Cmax) of MT-2990(Up to Day 113)
- Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990(Up to Day 113)
- Total nasal symptom score (TNSS)(Day 8, 29, 57, and 85)
- Total ocular symptom score (TOSS)(Day 8, 29, 57, and 85)
- Total symptom score (TSS)(Day 8, 29, 57, and 85)
研究者
研究点 (1)
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