A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 13
- 主要终点
- Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
A safety study of KAN-101 in patients with celiac disease. The study has two parts:
- Part A - first in human study in which patients receive a single dose of KAN-101
- Part B - patients will receive three doses of either KAN-101 or placebo
详细描述
Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).
An overview of the two parts and proposed dose groups is given below:
- Part A (SAD): Patients will receive a single dose of KAN-101.
- Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Adults aged 18 to 70 years inclusive
- •Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
- •Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
- •Has followed a GFD for > 12 months immediately prior to study entry
- •Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
- •Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
- •Capable of understanding and complying with protocol requirements
- •Patient understands and has signed the informed consent form
排除标准
- •Refractory celiac disease
- •Selective IgA deficiency
- •Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
- •Previous treatment with tolerance-inducing therapies for celiac disease
- •Known wheat allergy
- •Part B only: History of hyperacute or prolonged symptoms following gluten exposure
- •Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
- •History of dermatitis herpetiformis
- •Pregnant or breastfeeding
研究组 & 干预措施
SAD Cohort 2
All enrolled patients will receive one dose of KAN-101 Dose B
干预措施: KAN-101 (Drug)
SAD Cohort 1
All enrolled patients will receive one dose of KAN-101 Dose A
干预措施: KAN-101 (Drug)
SAD Cohort 3
All enrolled patients will receive one dose of KAN-101 Dose C
干预措施: KAN-101 (Drug)
SAD Cohort 4
All enrolled patients will receive one dose of KAN-101 Dose D
干预措施: KAN-101 (Drug)
MAD Cohort 5
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
干预措施: KAN-101 (Drug)
MAD Cohort 5
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
干预措施: Placebo (Drug)
MAD Cohort 6
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
干预措施: KAN-101 (Drug)
MAD Cohort 6
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
干预措施: Placebo (Drug)
MAD Cohort 7
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
干预措施: KAN-101 (Drug)
MAD Cohort 7
All randomized patients will receive 3 doses of either KAN-101 Dose C 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)
时间窗: Up to 28 Days
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
次要结局
- Cmax(0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7)
- AUC Last(0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7)