NCT05352269Unknown1 期
Safety and Tolerability of Xbiome Gut Microbial Capsule XBI-302 in Healthy Volunteers
Shenzhen Xbiome Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年4月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The incidence and severity of all AEs and SAEs
研究概览
简要总结
This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers. The hypothesis of this study is that XBI-302 is safe and well tolerated with the proposed dosing regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate and sign the ICF.
- •Healthy adults 18-55 years of age, male and female.
- •For women of childbearing age, negative serum pregnancy test at Screening and negative serum pregnancy test confirmed at the admission to the Phase 1 unit.
- •Female participants must not be pregnant, lactating, or actively trying to become pregnant. Participants who are premenopausal and of childbearing potential must have two negative pregnancy tests (serum) and both female and male participants must use medically acceptable and effective contraceptive methods during the study period, including:
- •Having a male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for that female participant
- •Use of double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intra-uterine devices are acceptable
- •True abstinence, when this is in line with the preferred and usual lifestyle of the participant (Note: period abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- •Clinical laboratory test values (hematology, blood chemistry, routine stool test, urinalysis, etc.) are in the normal ranges or although it was outside the normal limits, the researchers determined that the participant will still be eligible within the screening period.
- •Participants have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m2) inclusive, and a body weight of at least 45 kilograms (kg).
排除标准
- •History of cardiovascular disease, immune system disease, malignant disease such as cancer, nervous system disease, hematological disease, endocrinological disease, and/or any other diseases that in the opinion of the investigator could impact assessments of safety or the gut microbiome.
- •Significant past medical history of GI conditions including inflammatory bowel disease, irritable bowel syndrome, celiac disease, history of GI malignancy or polyposis, C. difficile infection in past year.
- •GI symptoms that occur more than four times a month including acid reflux, nausea, vomiting, diarrhea, abdominal pain or cramps, abdominal distension, bloating, constipation.
- •Used oral antibiotics within 4 weeks prior to the first FMT dosing.
- •HIV infection and/or HBV/HCV infection.
- •Active tuberculosis and undergoing treatment.
- •History of mental illness, drug or alcohol abuse and/or any other behavioral issues that may impact study compliance.
- •Lactating women or participants who plan to become pregnant or conceive within half a year.
- •History of severe hypersensitivity (may cause difficulty in breathing).
- •Alcohol breathalyzer test positive, urine drug screening test positive, and/or smoker.
- •Participated in any other clinical trials within 3 months of first dose.
- •Participants with history of bowel or gastrointestinal surgery.
- •Participants who are immunosuppressed or immunocompromised, either by genetic, acquired or secondary to medication.
- •Participants who are experiencing symptoms associated with COVID-19 (including but not limited to cough, fever, shortness of breath, nausea, diarrhea, anhedonia, anosmia, ageusia or severe fatigue).
研究组 & 干预措施
Cohort 1 XBI-302
Experimental
40 XBI-302 capsules in 1 day
干预措施: XBI-302 (Biological)
Cohort 1 Placebo
Placebo Comparator
40 placebo capsules in 1 day
干预措施: XBI-302 Placebo (Biological)
Cohort 2 Placebo
Placebo Comparator
80 placebo capsules over 2 days
干预措施: XBI-302 Placebo (Biological)
Cohort 3 Placebo
Placebo Comparator
40 placebo capsules per day, once a week for 4 weeks.
干预措施: XBI-302 Placebo (Biological)
Cohort 4 Placebo
Placebo Comparator
80 placebo capsules over 2 days, once a week for 4 weeks.
干预措施: XBI-302 Placebo (Biological)
Cohort 3 XBI-302
Experimental
40 XBI-302 capsules per day, once a week for 4 weeks.
干预措施: XBI-302 (Biological)
Cohort 4 XBI-302
Experimental
80 XBI-302 capsules over 2 days, once a week for 4 weeks.
干预措施: XBI-302 (Biological)
Cohort 2 XBI-302
Experimental
80 XBI-302 capsules over 2 days
干预措施: XBI-302 (Biological)
结局指标
主要结局
The incidence and severity of all AEs and SAEs
时间窗: Day 28
The incidence and severity of all AEs and SAEs that are determined to be related to XBI-302 through Day 28.
次要结局
- The gut microbiome profile(Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm))
- The incidence of all AEs and SAEs(Day 28 and Week 12)
- Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations.(Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm))
- Change in functions of all organ systems via standard complete physical examinations.(Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm))
- The colonization of microbiota from donor(Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm))
- The incidence of gastrointestinal AEs(Weeks 1, 2, 3, and 4 (if applicable for the arm))
- Change in laboratory data of pre- and post-intervention as a measure of safety.(Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm))
- Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety.(Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm))
- The subjective experience of the taste acceptance as a measure of tolerability.(Weeks 1, 2, 3, and 4 (if applicable for the arm))
- The level of difficulty of swallowing FMT capsules as a measure of tolerability.(Weeks 1, 2, 3, and 4 (if applicable for the arm))
研究者
研究点 (1)
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