First-in-human Study of VE303 in Healthy Adult Volunteers
NCT ID: NCT04236778
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2017-11-28
2019-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Cohort 1
Cohort 1 received oral vancomycin followed by a single dose of VE303.
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 2
Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303.
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 3
Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303.
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 4
Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303.
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 5
Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 6
Cohort 6 received 21 days of 10 doses daily of VE303
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Cohort 7
Cohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 8
Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Cohort 9
Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days
VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Vancomycin only
This cohort only received oral vancomycin.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Interventions
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VE303
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral Vancomycin
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 18.5 and 30 kg/m2
* Women either of non-child bearing potential or using a highly effective form of contraception
* Men using a highly effective method of contraception
Exclusion Criteria
* Taking any medications, herbal preparations, or natural substances, live bacteria products, or food that impacts or alter GI flora
* Use of proton pump inhibitors or other short or long acting antacid medications
* Taking or has received an investigation drug or treatment within 60 days of inpatient admission
* Known allergies to involved study drugs
* Chronic constipation or diarrhea
* History of or active IBD
18 Years
60 Years
ALL
Yes
Sponsors
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Vedanta Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Pharmaron CPC
Baltimore, Maryland, United States
Countries
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Other Identifiers
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VE303-01
Identifier Type: -
Identifier Source: org_study_id
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