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| Name | Class |
|---|---|
| Beijing Improve-Quality Tech.Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 XBI-302 | Experimental | 40 XBI-302 capsules in 1 day |
|
| Cohort 1 Placebo | Placebo Comparator | 40 placebo capsules in 1 day |
|
| Cohort 2 XBI-302 | Experimental | 80 XBI-302 capsules over 2 days |
|
| Cohort 2 Placebo | Placebo Comparator | 80 placebo capsules over 2 days |
|
| Cohort 3 XBI-302 | Experimental | 40 XBI-302 capsules per day, once a week for 4 weeks. |
|
| Cohort 3 Placebo | Placebo Comparator | 40 placebo capsules per day, once a week for 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XBI-302 | Biological | Fecal Microbiota Transplantation Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all AEs and SAEs | The incidence of all AEs and SAEs through Day 28 and Week 12. | Day 28 and Week 12 |
| Change in laboratory data of pre- and post-intervention as a measure of safety. |
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Inclusion Criteria:
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.
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuemei Liu | Contact | 010-83605200-855 | xuemei.liu@gohealtharo.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Hou, MD | Bejing Goboard Boren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bejing Goboard Boren Hospital | Recruiting | Beijing | China |
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| Cohort 4 XBI-302 | Experimental | 80 XBI-302 capsules over 2 days, once a week for 4 weeks. |
|
| Cohort 4 Placebo | Placebo Comparator | 80 placebo capsules over 2 days, once a week for 4 weeks. |
|
| XBI-302 Placebo | Biological | XBI-302 Placebo |
|
Compare changes laboratory data via hematology, blood chemistry, urinalysis, and routine stool testing before and after using FMT capsules.
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm) |