NCT04593251已完成1 期
A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 15
- 主要终点
- Incidence of treatment-emergent adverse event
研究概览
简要总结
This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.
详细描述
This is a multi-site, randomized, placebo controlled single and multiple dose escalation study of an anti-IL-15 mAb (CALY-002). The study initiates as placebo controlled, randomized trial with a single ascending dosing part in healthy subjects and commences with a multiple ascending dosing part in participants with Celiac Disease undergoing a gluten challenge and includes open label multiple dose expansion cohorts in participants with Eosinophilic Esophagitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A. Healthy Subjects:
- •Male or female aged between 18 and 50 years (both inclusive)
- •Must be healthy on the basis of the physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead electrocardiogram [ECG] results) performed at screening, in the opinion of the investigator
- •Part B. Subjects with Celiac Disease (CeD):
- •Male or female ≥ 18 years of age.
- •Diagnosis of CeD by intestinal biopsy at least 12 months prior to screening as confirmed by medical records.
- •No histological signs of active CeD at screening
- •Gluten-free diet (GFD) for at least 12 consecutive months prior to screening
- •Willing to undertake a gluten challenge (intake of approximately 3 g of gluten daily) for 56 consecutive days
- •Must be healthy on the basis of physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead ECG results) performed at screening, in the opinion of the investigator.
- •Part C. Subjects with Eosinophilic Esophagitis (EoE):
- •Male or female ≥ 18 years of age.
- •Must have endoscopically confirmed and documented diagnosis of EoE
- •Should exhibit active symptoms of dysphagia with more than 3 episodes of dysphagia during a period of 2 weeks during screening.
- •Must have clinically active disease
- •Must have had a relapsed EoE or did not respond after first line therapy
- •Subject must be healthy on the basis of physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead ECG results) performed at screening, in the opinion of the investigator.
排除标准
- •Part A. Healthy Subjects excluded:
- •Any significant medical condition, laboratory abnormality, or psychiatric illness
- •Any condition that confounds the ability to interpret data from the study.
- •Currently receiving or has been previously treated with a biologic agent.
- •History of anaphylactic reactions to protein therapeutics.
- •Has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require parenteral antibiotic administration.
- •Has evidence of SARS-CoV-2 infection and/or subject Is deemed at risk for the coronavirus disease (COVID-19)
- •Has had major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening.
- •Part B. Subjects with Celiac Disease (CeD) excluded:
- •A concurrent active autoimmune disease (other than CeD) that requires systematic treatment with immunosuppressants.
- •Has severe complication of CeD such as refractory CeD.
- •Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
- •Is currently receiving or has been previously treated with a biologic agent.
- •Has a history of anaphylactic reactions to protein therapeutics.
- •Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).
- •Part C: Subjects with Eosinophilic Esophagitis (EoE) excluded:
- •Has a hyper-eosinophilic syndrome.
- •Has a concurrent active autoimmune disease (other than EoE) that requires treatment with immunosuppressants.
- •Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
- •Currently receiving or has been previously treated with a biologic agent.
- •Has a history of anaphylactic reactions to protein therapeutics.
- •Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).
结局指标
主要结局
Incidence of treatment-emergent adverse event
时间窗: through study completion, an average of 3 months post last dose
次要结局
未报告次要终点
研究者
研究点 (15)
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