A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 21
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
研究概览
简要总结
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
- •Be on a GFD for at least 12 months
- •HLA-DQ2.5 genotype
- •Experienced at most mild symptoms of celiac disease
排除标准
- •Refractory celiac disease
- •Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
研究组 & 干预措施
SAD Cohort 1
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
干预措施: DONQ52 (Drug)
SAD Cohort 1
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
干预措施: Placebo (Drug)
MAD Cohort 2
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
干预措施: Placebo (Drug)
MAD Cohort 3
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
干预措施: DONQ52 (Drug)
SAD Cohort 2
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
干预措施: DONQ52 (Drug)
SAD Cohort 2
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
干预措施: Placebo (Drug)
SAD Cohort 3
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
干预措施: DONQ52 (Drug)
SAD Cohort 3
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
干预措施: Placebo (Drug)
SAD Cohort 4
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
干预措施: DONQ52 (Drug)
SAD Cohort 4
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
干预措施: Placebo (Drug)
MAD Cohort 1
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
干预措施: DONQ52 (Drug)
MAD Cohort 1
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
干预措施: Placebo (Drug)
MAD Cohort 2
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
干预措施: DONQ52 (Drug)
MAD Cohort 3
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
时间窗: Up to 246 days
Incidence and severity of TEAEs and its relationship to the study drugs
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
时间窗: Up to 246 days
Abnormality in Electrocardiograms (ECGs)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
时间窗: Up to 246 days
Incidence of laboratory abnormalities, based on clinical laboratory tests
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
时间窗: Up to 246 days
Abnormality in vital signs
次要结局
- Pharmacokinetics; Serum DONQ52 concentration(Up to 246 days)
- Pharmacokinetics; Area under the serum concentration time curve [AUC](Up to 246 days)
- Pharmacokinetics; Half life [T1/2](Up to 246 days)
- Pharmacokinetics; Maximum serum concentration [Cmax](Up to 246 days)
- Pharmacokinetics; Time to maximum serum concentration [Tmax](Up to 246 days)
- Immunogenicity(Up to 246 days)