2025-521560-36-00招募中2 期
A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D)
Sab Biotherapeutics Inc.4 个研究点 分布在 2 个国家目标入组 11 人开始时间: 2026年2月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Recording and reviewing any health problems or side effects that occur during the study
研究概览
简要总结
- To learn about the safety and tolerability of two study treatment regimens in people recently diagnosed with Stage 3 type 1 diabetes.
- To find out whether the study treatment can help slow the decline of insulin‑producing cells in the pancreas over the course of the study.
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
- 是
入选标准
- •Participants must be up to 40 years old and recently diagnosed with Stage 3 type 1 diabetes
- •Participants must be up to date with vaccines required by local or national health authorities
- •If female, participants must meet conditions that prevent pregnancy during the study (for example, not having started menstruation, being post‑menopausal, having had certain surgeries, or using reliable birth control)
- •Participants must have a positive test for at least one antibody linked to type 1 diabetes
- •Participants must agree not to take part in other experimental treatments during the study.
排除标准
- •Participants cannot have a known allergy or severe reaction to similar medicines or any ingredient in the study treatment
- •Participants cannot have taken part in another clinical trial within a set period before joining this study
- •Participants cannot have another autoimmune disease that requires immune system affecting treatment (except stable thyroid or celiac disease)
- •Participants cannot have serious health problems affecting the heart, liver, kidneys, or immune system, or have uncontrolled diabetes complications
- •Participants cannot have certain infections such as HIV, hepatitis B, or hepatitis C
结局指标
主要结局
Recording and reviewing any health problems or side effects that occur during the study
Recording and reviewing any health problems or side effects that occur during the study
Checking measures of pancreas function related to insulin production
Checking measures of pancreas function related to insulin production
次要结局
- Monitoring blood sugar control, including information from continuous glucose monitoring devices
研究者
Senior Vice President of Regulatory Affairs / Quality
Scientific
Sab Biotherapeutics Inc.
研究点 (4)
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