Acute-graft-versus-host DiseasePhase 1NCT05352269
Safety and Tolerability of FMT Capsules in Healthy Volunteers
A Phase 1 study testing XBI-302 in people with Acute-graft-versus-host Disease, run by Shenzhen Xbiome Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute-graft-versus-host Disease
- What is being tested?
- XBI-302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2022to Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Bejing Goboard Boren Hospital
Beijing
Xuemei Liu, 010-83605200-855, xuemei.liu@gohealtharo.com
Fang Hou, MD
About this study
Official title: Safety and Tolerability of Xbiome Gut Microbial Capsule XBI-302 in Healthy Volunteers
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.
- Conditions
- Acute-graft-versus-host Disease
- Being tested
- XBI-302, XBI-302 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XBI-302Biological
Fecal Microbiota Transplantation Capsules
XBI-302 PlaceboBiological
XBI-302 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 XBI-302 | Experimental | 40 XBI-302 capsules in 1 day Receives: Biological: XBI-302 |
| Cohort 1 Placebo | Placebo comparator | 40 placebo capsules in 1 day Receives: Biological: XBI-302 Placebo |
| Cohort 2 XBI-302 | Experimental | 80 XBI-302 capsules over 2 days Receives: Biological: XBI-302 |
| Cohort 2 Placebo | Placebo comparator | 80 placebo capsules over 2 days Receives: Biological: XBI-302 Placebo |
| Cohort 3 XBI-302 | Experimental | 40 XBI-302 capsules per day, once a week for 4 weeks. Receives: Biological: XBI-302 |
| Cohort 3 Placebo | Placebo comparator | 40 placebo capsules per day, once a week for 4 weeks. Receives: Biological: XBI-302 Placebo |
| Cohort 4 XBI-302 | Experimental | 80 XBI-302 capsules over 2 days, once a week for 4 weeks. Receives: Biological: XBI-302 |
| Cohort 4 Placebo | Placebo comparator | 80 placebo capsules over 2 days, once a week for 4 weeks. Receives: Biological: XBI-302 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (11)
The incidence of all AEs and SAEs
The incidence of all AEs and SAEs through Day 28 and Week 12.
Measured: Day 28 and Week 12
Change in laboratory data of pre- and post-intervention as a measure of safety.
Compare changes laboratory data via hematology, blood chemistry, urinalysis, and routine stool testing before and after using FMT capsules.
Measured: 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.
Change in functions of all organ systems via standard complete physical examinations.
Measured: 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.
Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations.
Measured: 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.
Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety.
Measured: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
The incidence of gastrointestinal AEs
Compare the incidence of gastrointestinal AEs on the dosing day(s) between treatment groups.
Measured: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The level of difficulty of swallowing FMT capsules as a measure of tolerability.
Estimate degree of difficulty of swallowing FMT capsules via daily diary cards by selecting easy, ok, hard (must rest frequently to complete all capsules), or very hard (stuck to my throat all the time, took a long time to finish all capsules).
Measured: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The subjective experience of the taste acceptance as a measure of tolerability.
Estimate degree of taste acceptance of FMT capsules via daily diary cards by selecting none, ok, a strange taste, or strong taste that makes me nauseous.
Measured: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The gut microbiome profile
Compare the gut microbiome profile before and after the transplantation between treatment groups.
Measured: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The gut microbiome profile
Compare the gut microbiome profile before and after the transplantation between donors and participants.
Measured: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The colonization of microbiota from donor
Compare the effects of diet and lifestyle on the colonization of microbiota from donor before and after FMT.
Measured: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start21 Apr 2022
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Improve-Quality Tech.Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fang Hou, MD, Principal investigator, Bejing Goboard Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352269
- Sponsor's protocol ID
- XBI302CT9001
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Xbiome Gut Microbial Capsule XBI-302 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05352269
- Acronym / sponsor ID
- XBI302CT9001
- Conditions
- Acute-graft-versus-host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shenzhen Xbiome Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Improve-Quality Tech.Co., Ltd.
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 XBI-302 | Experimental | Biological: XBI-30240 XBI-302 capsules in 1 day |
| Cohort 1 Placebo | Placebo comparator | Biological: XBI-302 Placebo40 placebo capsules in 1 day |
| Cohort 2 XBI-302 | Experimental | Biological: XBI-30280 XBI-302 capsules over 2 days |
| Cohort 2 Placebo | Placebo comparator | Biological: XBI-302 Placebo80 placebo capsules over 2 days |
| Cohort 3 XBI-302 | Experimental | Biological: XBI-30240 XBI-302 capsules per day, once a week for 4 weeks. |
| Cohort 3 Placebo | Placebo comparator | Biological: XBI-302 Placebo40 placebo capsules per day, once a week for 4 weeks. |
| Cohort 4 XBI-302 | Experimental | Biological: XBI-30280 XBI-302 capsules over 2 days, once a week for 4 weeks. |
| Cohort 4 Placebo | Placebo comparator | Biological: XBI-302 Placebo80 placebo capsules over 2 days, once a week for 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XBI-302Fecal Microbiota Transplantation Capsules | Biological | Cohort 1 XBI-302, Cohort 2 XBI-302, Cohort 3 XBI-302, Cohort 4 XBI-302 |
| XBI-302 PlaceboXBI-302 Placebo | Biological | Cohort 1 Placebo, Cohort 2 Placebo, Cohort 3 Placebo, Cohort 4 Placebo |
Primary outcome
The incidence and severity of all AEs and SAEs
Time frame: Day 28
The incidence and severity of all AEs and SAEs that are determined to be related to XBI-302 through Day 28.
11 secondary outcomes
The incidence of all AEs and SAEs
Time frame: Day 28 and Week 12
Change in laboratory data of pre- and post-intervention as a measure of safety.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
The incidence of gastrointestinal AEs
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The level of difficulty of swallowing FMT capsules as a measure of tolerability.
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The subjective experience of the taste acceptance as a measure of tolerability.
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The gut microbiome profile
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The gut microbiome profile
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The colonization of microbiota from donor
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Hou, MD principal investigator
Bejing Goboard Boren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XBI-302 in people with Acute-graft-versus-host Disease, run by Shenzhen Xbiome Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuemei Liu (010-83605200-855, xuemei.liu@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of all AEs and SAEs (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.