NCT05126316已完成1 期
Multiple-dose Safety, Pharmacokinetic and Pharmacodynamic Trial, in Subjects With Allergic Rhinitis
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
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The main goal of this trial is to learn more about the safety of repeated dosing with Lu AG09222. The trial doctors will keep track of the participant's overall health by asking them how they are and by analyzing blood and urine samples.
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
- 否
入选标准
- •The participant has a body mass index (BMI) ≥18.0 and ≤30 kilograms (kg)/square meter (m^2) at the screening visit.
- •The participant has a clinical history of grass pollen allergic rhinitis of at least 2 years' duration as diagnosed by a physician.
- •The participant has a positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kilounits [kU]/liter [L]) against Phleum pratense at screening.
- •The participant has a positive skin prick test with a wheal size ≥3 mm to Phleum pratense at screening.
- •The participant is, in the opinion of the investigator, generally healthy based on medical history (despite the allergic rhinitis), a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
排除标准
- •The participant has received sublingual or subcutaneous immunotherapy with Phleum pratense within the last 5 years.
- •The participant is receiving ongoing treatment with any allergy immunotherapy product.
- •The participant has a clinically relevant history of symptomatic (seasonal or perennial) allergy caused by an allergen source overlapping with the allergen challenge period.
- •The participant has taken disallowed medication or received a COVID-19 vaccination within the protocol-specified amount of time before Day
- •The participant has a relevant history of systemic allergic reaction, for example anaphylaxis with cardiorespiratory symptoms, generalized urticaria, or severe facial angioedema, which in the opinion of the investigator may constitute an increased safety concern.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Lu AG09222 Low Dose
Experimental
Participants will receive Lu AG09222 injection at a low dose level 3 times with 4 weeks between each administration.
干预措施: Lu AG09222 (Drug)
Lu AG09222 High Dose
Experimental
Participants will receive Lu AG09222 injection at a high dose level 3 times with 4 weeks between each administration.
干预措施: Lu AG09222 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matching to Lu AG09222 injection 3 times with 4 weeks between each administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Baseline (Day 1) up to Week 20
次要结局
- Apparent Elimination Half-Life of Lu AG09222(Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84)
- Area Under the Serum Concentration-Time Curve in the Last Dosing Interval (AUC0-τ) of Lu AG09222(Up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84)
- Time to Maximum Observed Concentration (Tmax) of Lu AG09222(Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84)
- Change from Baseline to Week 8 in Wheal-Reaction Area at 20 and 120 Minutes After Allergen Challenge(Baseline, Week 8)
- Maximum Observed Concentration (Cmax) of Lu AG09222(Predose on Days 1 and 57; up to 96 hours post last dose on Days 57 to 61; and on Days 64, 71, 78, and 84)
- Change from Baseline to Week 8 in Flare-Reaction Area at 20 and 120 Minutes After Allergen Challenge(Baseline, Week 8)
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
A Study Investigating Lu AG06474 in Healthy Young ParticipantsHealthy ParticipantsNCT05943327H. Lundbeck A/S56
已完成
1 期
Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese SubjectsHealthyNCT00434187Wyeth is now a wholly owned subsidiary of Pfizer24
已完成
1 期
Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male VolunteersHealthyNCT02331277Boehringer Ingelheim12
终止
1 期
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)Type 2 Diabetes MellitusNCT01614782Merck Sharp & Dohme LLC24
终止
1 期
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsAlzheimer's DiseaseNCT02220738AbbVie19