A Dose Ranging Target Engagement Study of a Food-Grade Pectic Food Supplement (G3P-01) in Volunteers With Elevated Levels of Galectin-3 - the Galaxy Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)
研究概览
简要总结
G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Invited through cohort study.
- •Plasma galectin-3 level of 16 ng/mL or higher
- •Male and female subjects ≥45 and ≤75 years of age
- •Females will be non-pregnant, non-lactating, and have no intent to become pregnant during the study period.
- •Able to participate in the study in the opinion of the Investigator.
- •Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
- •An Independent Ethics Committee or in Dutch Medisch- Ethische Toetsingscommissie (METC) -approved informed consent is signed and dated prior to any study-related activities.
排除标准
- •Existing clinically significant concurrent medical condition which in the opinion of the Investigator may interfere with the study.
- •Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening.
- •Participation in a clinical trial of an investigational drug within 30 days prior to Screening, or is currently participating in another trial of an investigational drug, supplement or device.
结局指标
主要结局
To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)
时间窗: 4 months
Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics
To evaluate tolerability of G3P-01
时间窗: 4 months
Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)
次要结局
未报告次要终点