2025-524449-28-00招募中1 期
A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence and severity of AEs, TEAEs, and SAEs
研究概览
简要总结
To evaluate the safety and tolerability of IMC-S118AI when administered as a single and multiple doses in participants with T1D
研究设计
- 分配方式
- Randomized
- 主要目的
- Part 2
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age: 12 to 45 yrs
- •HLA type: HLA-A*02:01
- •Body mass index (BMI): 18 to 25 kg/m2
- •History of a diagnosis of T1D
- •Shows signs of remaining beta-cell function
排除标准
- •Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)
- •History of recurrent hypoglycaemia due to non-compliance with insulin regimens
- •Prior treatment with immunomodulating therapy for T1D
- •Have a history of cardiovascular disease or impaired cardiac function
- •Current diagnosis of a malignancy or any history of malignancy
研究组 & 干预措施
0.9% Sodium Chloride Intravenous Infusion Solution
Placebo
干预措施: 0.9% Sodium Chloride Intravenous Infusion Solution (Drug)
IMC-S118AI
Test
干预措施: IMC-S118AI (Drug)
结局指标
主要结局
Incidence and severity of AEs, TEAEs, and SAEs
Incidence and severity of AEs, TEAEs, and SAEs
Changes in safety laboratory parameters, vital signs, and electrocardiogram
Changes in safety laboratory parameters, vital signs, and electrocardiogram
Incidence of dose interruptions, reductions, and discontinuations
Incidence of dose interruptions, reductions, and discontinuations
次要结局
- IMC-S118AI PK parameters after single and multiple doses
- Incidence of anti-IMC-S118AI antibody formation
- Change from Baseline in AUC of serum C-peptide at Week 25 in participants treated with IMC-S118AI compared to placebo
研究者
Regulatory Affairs
Scientific
Immunocore Limited
研究点 (2)
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