Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
研究概览
简要总结
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
详细描述
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents
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)
盲法说明
Double blind placebo controlled trial
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly Diagnosed children (age 11-17 years old)
- •BMI <85%
- •Diagnosed by ADA criteria with T1D within 2 years
- •Accepted to adhere to a healthy diabetic diet as recommended by the ADA
排除标准
- •Monogenic forms of diabetes or type 2 diabetes
- •History of ongoing infection or antibiotic treatment within the past four (4) weeks
- •History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
- •History of chronic gastrointestinal disease, possible or confirmed celiac disease
- •Pregnancy or possible pregnancy
- •Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
- •Participation in other intervention research trials within the past three (3) months
- •Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
- •Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
- •Any COVID vaccines within 30 days prior to Day 1
研究组 & 干预措施
Active Comparator
R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)
干预措施: R-5280 (Drug)
Placebo Comparator
Food starch, taken twice a day, orally with food for 12 weeks (84 days)
干预措施: Placebo (Other)
结局指标
主要结局
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
时间窗: 12 Weeks
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
次要结局
- Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes(12 Weeks)