Safety and Tolerability of FMT Capsules in Healthy Volunteers
Safety and Tolerability of Xbiome Gut Microbial Capsule XBI-302 in Healthy Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedStudy Start
First participant enrolled
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 6, 2022
April 1, 2022
3 months
April 12, 2022
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence and severity of all AEs and SAEs
The incidence and severity of all AEs and SAEs that are determined to be related to XBI-302 through Day 28.
Day 28
Secondary Outcomes (11)
The incidence of all AEs and SAEs
Day 28 and Week 12
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 functions of all organ systems via standard complete physical examinations.
Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
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 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)
- +6 more secondary outcomes
Study Arms (8)
Cohort 1 XBI-302
EXPERIMENTAL40 XBI-302 capsules in 1 day
Cohort 1 Placebo
PLACEBO COMPARATOR40 placebo capsules in 1 day
Cohort 2 XBI-302
EXPERIMENTAL80 XBI-302 capsules over 2 days
Cohort 2 Placebo
PLACEBO COMPARATOR80 placebo capsules over 2 days
Cohort 3 XBI-302
EXPERIMENTAL40 XBI-302 capsules per day, once a week for 4 weeks.
Cohort 3 Placebo
PLACEBO COMPARATOR40 placebo capsules per day, once a week for 4 weeks.
Cohort 4 XBI-302
EXPERIMENTAL80 XBI-302 capsules over 2 days, once a week for 4 weeks.
Cohort 4 Placebo
PLACEBO COMPARATOR80 placebo capsules over 2 days, once a week for 4 weeks.
Interventions
Fecal Microbiota Transplantation Capsules
XBI-302 Placebo
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bejing Goboard Boren Hospital
Beijing, China
Study Officials
- PRINCIPAL INVESTIGATOR
Fang Hou, MD
Bejing Goboard Boren Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 28, 2022
Study Start
April 21, 2022
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
May 6, 2022
Record last verified: 2022-04