NCT05516225已完成1 期
Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers
Prolacta Bioscience1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年9月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.5 and 24.9 kg/m2
- •Age between 18 and 50 years old
- •No diagnosed medical conditions
- •No significant change to diet in the 2 weeks prior to enrollment
- •Agreement to use contraception for female subjects
排除标准
- •Lactose intolerance
- •Pregnancy
- •Lactation
- •Enrollment in another clinical study
研究组 & 干预措施
PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days
Experimental
干预措施: PBCLN-003 (Drug)
PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days
Experimental
干预措施: PBCLN-003 (Drug)
PBCLN-003, 9 g daily in 3 divided oral doses for 7 days
Experimental
干预措施: PBCLN-003 (Drug)
PBCLN-003, 18 g daily in 3 divided oral doses for 7 days
Experimental
干预措施: PBCLN-003 (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 28 days
Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram.
次要结局
- Stool, saliva, and vaginal microbiome(28 days)
- Serum cytokine levels(28 days)
研究者
研究点 (1)
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